Apparatuses for the amelioration of urinary incontinence in females

ABSTRACT

An apparatus for treating urinary incontinence, comprising: a support section adapted for providing urethral support; an anchoring section for resisting movement of the apparatus; an insert, a portion of which is adapted to be positioned where the support section attaches to the node; and, wherein the insert urges the support section radially outwards from a central axis of the apparatus.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/886,248 filed on Sep. 13, 2007, which is a National Phase of PCTPatent Application No. PCT/IL2006/000346 having International FilingDate of Mar. 16, 2006, which is a continuation-in-part of PCTApplication No. PCT/IL2005/000304 filed on Mar. 17, 2005, now publishedas WO 2005/087154 and entitled “Apparatus for the Prevention of UrinaryIncontinence in Females” and a continuation-in-part of PCT PatentApplication No. PCT/IL2004/000433 filed on May 20, 2004, now publishedas WO 2004/000433, the disclosures of which are herein incorporated byreference. Those related applications also claim the benefit of priorityunder 35 USC 119(e) of U.S. Provisional Patent Application Nos.60/553,964 filed on Mar. 18, 2004; 60/555,977 filed on Mar. 25, 2004;60/570,469 filed on May 13, 2004; 60/570,535 filed on May 13, 2004;60/598,835 filed on Aug. 5, 2004; 60/602,636 filed on Aug. 19, 2004, thedisclosures of which are herein incorporated by reference. In additionto the above, PCT Patent Application No. PCT/IL2006/000346 claims thebenefit of priority under 35 USC 119(e) of U.S. Provisional PatentApplication Nos. 60/719,422 filed on Sep. 22, 2005 and 60/762,059 filedon Jan. 25, 2006, the disclosures of which are herein incorporated byreference.

FIELD OF INVENTION

The present invention relates generally to treating feminine medicalconditions, for example by providing devices for the prevention offemale incontinence and/or prolapse.

BACKGROUND OF THE INVENTION

Urinary incontinence is a widespread problem among females. It isestimated that up to 50% of women occasionally leak urine involuntarily,and that approximately 25% of women will seek medical advice at somepoint in order to deal with the problem. Stress incontinence, the mostcommon type of urinary incontinence, refers to the involuntary loss ofurine resulting from abdominal pressure rise occurring during exercise,coughing, sneezing, laughing, etc. While many different factors maycontribute to the development of stress incontinence, it is mostprevalent among women ages 35-65 and those who have had multiple vaginaldeliveries. Stress incontinence is both aggravating and unpleasant forwomen, and it can also be embarrassing. Many women wear sanitary pads ordiapers in order to deal with incontinence, though this is not a realsolution to the problem and it can be very inconvenient and unreliable.Surgical treatment may involve securing the paraurethal tissues to theperiosteum of the pubic bone or the rectus facia in order to elevate thebladder neck above the pelvic floor and thereby distribute pressureequally to the bladder, the bladder neck, and the mid-urethra. Recently,a procedure known as “TVT” (“Tension Free Vaginal Tape”) was developed,in which a mesh tape is implanted underneath the mid-urethra, creating ahammock on which the urethra may kink during a rise in intra-abdominalpressure. However, surgery is only suitable for severe cases, and themajority of women experiencing incontinence do not need, and certainlywould rather avoid, surgical solutions.

One modality of non-surgical treatment involves the use of devices thatare inserted into the vagina, either by a medical practitioner or by thewoman herself. Most devices are designed to apply pressure against thebladder neck so as to inhibit or completely block the flow of urinethrough the urethra. A variety of such devices are known in the art. Forexample, refer to U.S. Publication No. 2002/0183711 to Moser, entitled,“Urinary Incontinence Device”; U.S. Pat. No. 6,739,340 to Jensen, etal., entitled, “Device for prevention of involuntary urination”; U.S.Pat. No. 6,679,831 to Zunker, et al., entitled, “Resilient incontinenceinsert and a method of making the same”; U.S. Pat. No. 6,460,542 toJames, entitled, “Female incontinence control device”; U.S. Pat. No.6,413,206 to Biswas, entitled, “Intra-vaginal device”; U.S. Pat. No.5,785,640 to Kresch, entitled “Method for Treating Female Incontinence”;U.S. Pat. No. 5,771,899 to Martelly, et al., entitled, “Pessary”; U.S.Pat. No. 5,618,256 to Reimer, entitled, “Device for Arrangement in theVagina for Prevention of Involuntary Urination with Females and anApplicator for use in Insertion of the Device”; U.S. Pat. No. 5,417,226to Juma, entitled, “Female Anti-Incontinence Device”; U.S. Pat. No.5,386,836 to Biswas, entitled, “Urinary Incontinence Device”; U.S. Pat.No. 5,007,894 to Enhorning, entitled, “Female Incontinence Device”; andU.S. Pat. No. 4,920,986 to Biswas, entitled, “Urinary IncontinenceDevice”, the disclosures of which are herein incorporated by reference.

One problem with many of the above listed devices is that theycompletely block the urethra and thus they need to be removed orcollapsed in order to allow the woman to urinate. To overcome thisdrawback, vaginal devices have been developed having specialized shapesthat do not completely block the urethra but these devices tend to belarge, uncomfortable, and intrusive. They also tend to cause irritationor soreness to the vagina.

Another common shortcoming is that most devices known in the art alsotend to be difficult or painful to insert and/or remove. In order tocorrectly inhibit urine flow, the device needs to be properly positionedin the vaginal canal. As a result, a doctor may be required to properlyposition the device. In most cases, the device is adapted for remainingin the vagina for a prolonged period of time (due to the time andexpense of requiring a trained medical professional to insert thedevice). However, when positioned in the vagina for an extended periodof the time, the device may cause vaginal infections, necrosis, orbleeding.

SUMMARY OF THE INVENTION

An aspect of some exemplary embodiments of the invention relates toproviding incontinence devices with inserts adapted to provide resilientreinforcement to at least a portion of the device. Optionally, theincontinence devices are provided with support arms. In some exemplaryembodiments, an insert is used in conjunction with the support arms ofthe incontinence device to provide urethral support to a patient. In anexemplary embodiment of the invention, the insert urges the support armsto expand radially (radially outwards from a central axis of the device)for providing urethral support. Optionally, radial expansion is up to20% of the previous radial profile of the device. Optionally, radialexpansion is up to 50% of the previous radial profile of the device. Insome embodiments, radial expansion is more than 50% of the previousradial profile of the device. In some exemplary embodiments of theinvention, an insert is located at the convergence of the support armsat a central node of the incontinence device. In some exemplaryembodiments of the invention, the insert penetrates the central node ofthe incontinence device. In some exemplary embodiments of the invention,the insert is positioned on a surface of the device, an interiorsurface, which is located opposite a vaginal wall.

In an exemplary embodiment of the invention, the insert is conicalshaped. Optionally, the insert is geometrically locking. Optionally, theinsert is of varying geometry. Optionally, the insert is bi-stable.Optionally, the insert is an o-ring. Optionally, the insert is comprisedof a plurality of components removably fitted together. Optionally, atleast a portion of the insert is elastic. In some exemplary embodimentsof the invention, the insert locks into at least one position on theincontinence device. In some exemplary embodiments of the invention, theinsert removably locks into position on the incontinence device. In someexemplary embodiments of the invention, the insert is positioned inrelation to the incontinence device such that support and/or pressureare rendered to the anchor arms of the device.

In some exemplary embodiments of the invention, the incontinence deviceis deployed using an applicator, such as those described herein and inrelated applications. The incontinence device is optionally providedwith a removal device for removing the device from the vagina after use.In some exemplary embodiments of the invention, the incontinence deviceis provided with a cover. Optionally, urethral support is mid-urethralsupport.

In some exemplary embodiments of the invention, an incontinence deviceis provided with an internal and/or external resilient support member.Optionally, the resilient support member biases arms of the incontinencedevice. Optionally, the resilient support member biases arms of theincontinence device radially outwards from a central axis of theincontinence device. Optionally, resilient support member biases arms ofthe incontinence device radially inwards towards a central axis of theincontinence device. Optionally, the resilient support member is usedfor at least the support arms of the incontinence device. Optionally,the resilient support member is used for at least the anchor arms of theincontinence device. Optionally, the insert is positioned in relation toan incontinence device such that support and/or pressure are rendered tothe support arms of the device. In some exemplary embodiments of theinvention, support rendered by insert to device is support against theforces exerted on the arms by a vaginal wall. In some exemplaryembodiments of the invention, the pressure urges the arms radiallyoutward from a central axis of the device, causing radial expansion ofthe device.

In some exemplary embodiments of the invention, an incontinence deviceis provided with tension reducing arms. Optionally, tension is reducedby providing the arms with a folding section. In some exemplaryembodiments of the invention, the tension reducing arms are folded whilein storage within an applicator, however upon deployment, the armsexpand to render support and/or anchoring.

An aspect of some exemplary embodiments of the invention relates toproviding an incontinence device with multiple stable configurations. Insome exemplary embodiments of the invention, an incontinence device isprovided with a component which is at least bi-stable. Optionally, thebi-stable component is provided with a first stable position, which doesnot cause the device to expand radially, and at least a second stableposition, which causes the device to expand radially. Optionally, thebi-stable component transfers from the first stable position to thesecond stable position without substantially moving in relation to theincontinence device. Optionally, the bi-stable component transfers fromthe first stable position to the second stable position by moving inrelation to the incontinence device. In some exemplary embodiments ofthe invention, the device is provided with a removal device which iscapable of changing the second stable position to the first stableposition. Optionally, the device is used with a cover. Optionally, thedevice is deployed in a vagina using an applicator.

An aspect of some exemplary embodiments of the invention relates toproviding an incontinence device which is comprised of differentcomponents with different material properties in order to achieve aparticular operational profile. For example, in some exemplaryembodiments of the invention, an insert is provided to the incontinencedevice where the insert is partially elastic and/or partially rigid.Optionally, a partially rigid insert is used to apply selectiveexpansion and/or retraction of support and/or anchoring sections of theincontinence device. Optionally, different components with differentmaterial properties are used to distribute forces exerted on and/or bythe incontinence device. In some exemplary embodiments of the invention,the incontinence device is comprised of different materials withdifferent material properties in order to provide effective incontinencetreatment.

An aspect of some exemplary embodiments of the invention relates toproviding at least a portion of an incontinence device withelasto-mechanical radial expansion. In some exemplary embodiments of theinvention, force is supplied for elasto-mechanical radial expansion byan elastic central member. Optionally, the elastic central member isoperationally connected to expanders (which in some embodiments aremechanical, hence the name “elasto-mechanical”) which cause radialexpansion of the device. Optionally, the device is provided with supportarms, which constitute a portion of the device which is radiallyexpanded. Optionally, the device is provided with anchor arms, whichconstitute a portion of the device which is radially expanded. In someexemplary embodiments of the invention, radial expansion of theincontinence device occurs upon ejection of the device from anapplicator. In some exemplary embodiments of the invention, the deviceis provided with a removal device which stops the elastic central memberfrom exerting force on the expanders thereby causing a radialcontraction of the device and/or enabling easier removal of the device.

An aspect of some exemplary embodiments of the invention relates toproviding an incontinence device with an elastomeric ring for assistingwith radial expansion and/or contraction of the device. In someexemplary embodiments of the invention, the elastomeric ring is used ina plurality of positions in relation to the device in order to provideradial expansion and/or contraction to the device. Optionally, theelastomeric ring slides along an exterior of the device in order toassume the plurality of positions. In some exemplary embodiments of theinvention, the shapes of the incontinence device and/or a pivot pieceassist the elastomeric ring with expansion and/or contraction of theincontinence device. In some exemplary embodiments of the invention, thedevice is provided with a removal device which dislodges the pivot pieceallowing for device contraction and/or easier removal of the device. Insome exemplary embodiments of the invention, the elastomeric ring is acomponent of a bi-stable incontinence device. In some exemplaryembodiments of the invention, the elastomeric ring is not flexible.Optionally, the elastomeric ring is not ring shaped; it is optionallysquare, rectangular, triangular, ovoid, or u-shaped, for example.

An aspect of some exemplary embodiments of the invention relates toproviding at least one tensile element to an incontinence device forproviding radial expanding force, but not compressive force, to thedevice. In some exemplary embodiments of the invention, at least onetensile element extends between an arm of an anchor section and acorresponding arm of a support section of the incontinence device.Optionally, the at least one tensile element is elastic. In someexemplary embodiments of the invention, the at least one tensile elementis stretched prior to deployment and while being stored in anapplicator. Optionally, the at least one tensile element substantiallyunstretches upon being deployed, setting providing expansion force tothe incontinence device as a function of the natural unstretched lengthof the connector. In some exemplary embodiments of the invention, the atleast one tensile element helps to resist movement of the supportsection and/or the anchor section after deployment of the device in thevagina. Optionally, the flexibility of the support section and/or anchorsection are adjusted depending on the desired response to the at leastone tensile element.

An aspect of some exemplary embodiments of the invention relates to anincontinence device which scrolls in order to increase and/or decreaseits size profile. In some exemplary embodiments of the invention, theincontinence device is rolled up around its central axis to reduce thediameter of the device. Optionally, the reduced diameter device isstored in an applicator prior to deployment. In an exemplary embodimentof the invention, when the scrolled incontinence device is deployed outof the applicator, it at least partially unrolls to assume a largerdiameter to provide support to the patient's urethra. Optionally, thescrolling device is provided with a plurality of protrusions foroffering support and/or anchoring. In some exemplary embodiments of theinvention, the device is adapted so that the arms and/or protrusions ofthe device position themselves on either side of the urethra; eitherdirectly upon deployment or after movement by the user causes slightrotation of the device. Optionally, the scrolling device is cylindrical.Optionally, the scrolling device has a larger diameter at one end thanthe other end.

In an exemplary embodiment of the invention, an incontinence device isprovided with a plurality of connected scrolling sections. Optionally,two scrolling sections are provided to incontinence device. Optionally,scrolling sections are connected by a flexible member. In some exemplaryembodiments of the invention, a scrolling section is located at each endof the flexible member. Optionally, scrolling sections are provided witha plurality of protrusions for offering support and/or anchoring. Insome exemplary embodiments of the invention, scrolling sections rollaround the central axis of the device to reduce their radial profile.Optionally, the reduced radial profile device is stored in anapplicator. In some exemplary embodiments of the invention, upondeployment of the incontinence device, scrolling sections unroll toassume a larger diameter to provide support to a patient's urethra.Optionally, support is mid-urethral.

An aspect of some exemplary embodiments of the invention relates toproviding lubrication at least to the external surface of an applicator.Optionally, the applicator is for inserting an incontinence device.Optionally, lubrication is provided by a reservoir ring positionedaround the circumference of the applicator. Optionally, the reservoirring is porous. Optionally, the reservoir ring is hollow. Optionally,lubrication is provided by a layer on the applicator which is revealedwhen a cover is removed. Optionally, lubrication is provided by amovable sleeve positioned on the applicator and wherein the lubricant islocated. In an exemplary embodiment of the invention, the applicator islubricated prior to insertion into the patient's vagina. Optionally, thering is removed after lubrication but prior to insertion. Optionally,the sleeve is removed after lubrication but prior to insertion.Optionally, an indicator, such as a ring, is used on the applicator toindicate the proper depth for insertion of the applicator in order toachieve effective device deployment. Optionally, the ring physicallystops the applicator at the proper depth for insertion of the applicatorin order to achieve effective device deployment.

An aspect of some exemplary embodiments of the invention relates toproviding applicators for extending the shelf life of incontinencedevices. Optionally, any radially expandable device is used with theshelf life extending applicators. In an exemplary embodiment of theinvention, an applicator is provided with a flared section for storageof at least the support section of an incontinence device. The flaredsection allows the support section to remain at least partiallyunstressed during storage. Optionally, a central node of theincontinence device is also located in flared section. Optionally, theflared section is sized to accommodate at least partially expanded armsof the incontinence device. Optionally the flared section is used toindicate the proper depth for insertion of the applicator in order toachieve effective device deployment.

In some exemplary embodiments of the invention, an applicator isprovided with a plurality of slots adapted and constructed toaccommodate arms of an incontinence device such that when incontinencedevice is located within the applicator the arms protrude outwardlyand/or uncompressed. Optionally, a movable sleeve is used to positionthe outwardly protruding arms inside the applicator in preparation fordeployment. Optionally, an indicator, such as a ring, is used on theapplicator to indicate the proper depth for insertion of the applicatorin order to achieve effective device deployment.

An aspect of some exemplary embodiments of the invention relates tominimizing the size of an incontinence device deployment package byreducing the size of a plunger used to deploy an incontinence devicefrom an applicator. In an exemplary embodiment of the invention, atelescoping plunger is provided. Optionally, the plunger is folded.Optionally, the telescoping plunger is comprised of at least twosections. Optionally, the plunger in a closed condition is approximatelyhalf its size when in a deployed condition. In an exemplary embodimentof the invention, a ring is located on the plunger to provide frictionbetween the plunger and an applicator during relative movement betweenthem. Optionally, the ring resists inadvertent dislodgment of theplunger form the applicator.

In an exemplary embodiment of the invention, the applicator contacts acentral portion, such as the node, of the incontinence device to deployit from the applicator. Optionally, the applicator deploys theincontinence device by contacting at least one support arm. In anembodiment of the invention, at least part of the applicator, such asthe plunger is used to help place the support arm into a deployedposition.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: asupport section adapted for providing urethral support; an anchoringsection for resisting movement of the apparatus; an insert, a portion ofwhich is adapted to be positioned proximal to the support section; and,wherein the insert selectively provides at least support to the supportsection of the apparatus. Optionally, the insert is adapted to providepressure to the support section, causing radial expansion of the supportsection. Optionally, the support section is flexible. In an exemplaryembodiment of the invention, the support section is comprised of atleast one support arm. Optionally, the insert is an o-ring. Optionally,the insert is flared. Optionally, the urethral support is mid-urethralsupport. In an exemplary embodiment of the invention, the apparatusfurther comprises a cover. Optionally, the insert is conical.Optionally, the insert is comprised of a plurality of geometricallyinterlocking elements. Optionally, the insert is comprised of at least asupporting protrusion and a locking protrusion. Optionally, the insertis an invertible membrane. Optionally, the insert is a ringed insert. Inan exemplary embodiment of the invention, the apparatus furthercomprises a resilient support member. Optionally, the resilient supportmember biases at least the support section towards a central axis of theapparatus. Optionally, the resilient support member biases at least thesupport section away from a central axis of the apparatus. Optionally,the support section and anchoring section are comprised of at least 2arms, respectively. Optionally, the arms are provided with a foldingsection. Optionally, the cover substantially encapsulates the apparatus.Optionally, at least the support section and the anchoring section areflexible. Optionally, the apparatus is flexible. In an exemplaryembodiment of the invention, the apparatus further comprises a removaldevice.

There is this provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: asupport section adapted for providing urethral support; an anchoringsection for resisting movement of the apparatus; and, an insert, adaptedto provide at least support to the support section and at least aportion of the insert being elastic. Optionally, the insert is comprisedof a plurality of components removably fitted together. Optionally, theinsert urges the support section radially outwards from a central axisof the apparatus. Optionally, the insert is provided with an expandedend which provides radial expansion to the anchoring section. In anexemplary embodiment of the invention, the apparatus further comprises acover. Optionally, the cover substantially encapsulates the apparatus.Optionally, at least the support section and the anchoring section areflexible. Optionally, the apparatus is flexible. In an exemplaryembodiment of the invention, the apparatus further comprises a removaldevice. Optionally, the urethral support is mid-urethral support.Optionally, the support section is comprised of at least one supportarm.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: asupport section adapted for providing urethral support; an anchoringsection for resisting movement of the apparatus; at least one expandernode, provided with at least one expander connected to the apparatus; anelastic member which passes through the at least one expander node; aremovable safety catch provided to an expanded end of the elastic memberwhich prevents expanded end from passing through the at least oneexpander node, and, wherein when the elastic member is substantiallyunstretched, the at least one expander causes radial expansion of theapparatus. In an exemplary embodiment of the invention, the apparatusfurther comprises a cover. Optionally, the cover substantiallyencapsulates the node, support section and the anchoring section.Optionally, at least the support section and the anchoring section areflexible. In an exemplary embodiment of the invention, the apparatusfurther comprises a removal device provided to the safety catch.Optionally, the urethral support is mid-urethral support. Optionally,the support section is comprised of at least one support arm.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: asupport section adapted for providing urethral support; an anchoringsection for resisting movement of the apparatus; a first groove; anelastomeric ring positioned on an exterior surface of the apparatuswithin the first groove; and, wherein the elastomeric ring providescompression force to at least a portion of the apparatus. Optionally,the elastomeric ring applies compression force to the support section toeffectuate radial contraction of the support section. In an exemplaryembodiment of the invention, the apparatus further comprises a secondgroove located between the first groove and the support section. In anexemplary embodiment of the invention, the apparatus further comprises apivot piece located in a third groove. Optionally, upon deployment theelastomeric ring transitions from the first groove to the second groovecausing radial expansion of the support and anchor sections. In anexemplary embodiment of the invention, the apparatus further comprises aremoval device attached at least to the pivot piece. In an exemplaryembodiment of the invention, the apparatus further comprises a cover.Optionally, the support and anchoring sections are flexible.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: asupport section adapted for providing urethral support; an anchoringsection for resisting movement of the apparatus; and, a tensile element,the tensile element attached to the support section and the anchoringsection and adapted to provide radial expansion to the apparatus.Optionally, the tensile element is elastic.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: asupport section adapted for providing urethral support; and, wherein theapparatus is provided with a first stable position and second stableposition, such that when apparatus is in the second stable position thesupport section renders support to the urethra. Optionally, the supportsection is provided with a plurality of support arms. In an exemplaryembodiment of the invention, the apparatus further comprises a bi-stablecomponent wherein the bi-stable component is attached to the supportsection. Optionally, the bi-stable component is a flexible membrane.Optionally, the bi-stable component is a locking element. Optionally,the bi-stable component is ring. In an exemplary embodiment of theinvention, the apparatus further comprises a first groove associatedwith the first stable position and a second groove associated with thesecond stable position. Optionally, the ring is slidable on an exteriorof the apparatus from the first groove to the second groove. In anexemplary embodiment of the invention, the apparatus further comprises aremoval device. Optionally, a removal device is attached to thebi-stable component for changing the second stable position to the firststable position.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: asupport section adapted to render support to a urethra; an insert, theinsert comprising a first material which exhibits first materialproperties and at least a second material which exhibits second materialproperties; and, wherein the insert selectively expands the supportsection. Optionally, the first material is flexible. Optionally, thesecond material is more rigid than the support section.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: acentral node, wherein the central node is a rolled sheet; a plurality ofsupport protrusions located on the node; and, a plurality of anchorprotrusions located on the node. Optionally, the central node whenrolled has a larger diameter on one end than the other end.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for treating urinary incontinence, comprising: aconnector; and, a plurality of scrolling sections. Optionally, theconnector is flexible. Optionally, the scrolling sections are providedwith a plurality of protrusions for rendering urethral support.Optionally, the scrolling sections are provided with a plurality ofprotrusions for rendering anchoring. Optionally, the plurality ofscrolling sections means two sections. Optionally, each of the twosections is located on an opposite end of the connector.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for inserting a vaginal device, comprising: anenclosure for containing the vaginal device; and a lubricating elementlocated externally of the enclosure. Optionally, the lubricating elementis a ring located around a circumference of the enclosure. Optionally,the lubricating element is a layer of lubricant applied to the enclosurewhich is revealed when a cover to the layer is removed. Optionally, thelubricating element is a movable sleeve located around a circumferenceof the enclosure. Optionally, the lubricating element is a layer oflubrication on the enclosure. Optionally, the lubrication is highlyviscous such that once lubrication is located on the enclosure itsubstantially remains in place until use.

There is thus provided in accordance with an exemplar embodiment of theinvention, an apparatus for extending the shelf life of a vaginallyinsertable device, comprising: an enclosure adapted for receipt of atleast a first portion of the device and vaginal insertion; a sectionadapted for receipt of at least a second portion of the device such thatthe second portion is at least partially expanded. Optionally, thesection is a flared enclosure. Optionally, the section is provided witha plurality of slots. Optionally, the slots are sized and numbered toaccommodate the second portion of the device. In an exemplary embodimentof the invention, the apparatus further comprises a slidable sleevelocated externally of the enclosure for repositioning the second portionof the device prior to insertion of the device into a vagina.

There is thus provided in accordance with an exemplary embodiment of theinvention, an apparatus for motivating a vaginally insertable device,comprising: an outer section, adapted for insertion into a vaginalapplicator; and, an inner section, capable of insertion into andmovement within the outer section. In an exemplary embodiment of theinvention, the apparatus further comprises a ring, wherein the ring islocated on the outer section such that friction is created by ring whenthere is movement of the apparatus relative to the applicator.

There is this provided in accordance with an exemplary embodiment of theinvention, a collapsible apparatus for inserting a vaginal device,comprising: an enclosure for containing the vaginal device; and aplunger adapted to coaxially fit within the enclosure. Optionally, theplunger is substantially located within the enclosure during storage.Optionally, an insert is provided to the vaginal device. Optionally, theinsert is attached to a removal/activator device. Optionally, theremoval activator device is removably latched to the plunger.Optionally, movement of the plunger out of the enclosure moves theinsert at least partially through the vaginal device.

BRIEF DESCRIPTION OF THE FIGURES

Non-limiting embodiments of the invention will be described withreference to the following description of exemplary embodiments, inconjunction with the figures. The figures are generally not shown toscale and any measurements are only meant to be exemplary and notnecessarily limiting. In the figures, identical structures, elements orparts which appear in more than one figure are preferably labeled with asame or similar number in all the figures in which they appear, inwhich:

FIG. 1A is a profile view of an incontinence device with a conicalinsert in accordance with an exemplary embodiment of the invention;

FIG. 1B is a profile view of an incontinence device with a conicalinsert during device removal in accordance with an exemplary embodimentof the invention;

FIG. 2A is a profile view of an incontinence device with a geometriclocking insert in an applicator in accordance with an exemplaryembodiment of the invention;

FIG. 2B is a profile view of an incontinence device with a geometriclocking insert being deployed in accordance with an exemplary embodimentof the invention;

FIG. 2C is a profile view of an incontinence device with a geometriclocking insert in a deployed position in accordance with an exemplaryembodiment of the invention;

FIG. 2D is a profile view of an incontinence device with a geometriclocking insert showing device removal in accordance with an exemplaryembodiment of the invention;

FIG. 3A is a profile view of an incontinence device with a varyinggeometry insert as in an applicator in accordance with an exemplaryembodiment of the invention;

FIG. 3B is a profile view of an incontinence device with a varyinggeometry insert as deployed in accordance with an exemplary embodimentof the invention;

FIG. 3C is a profile view of an incontinence device with a varyinggeometry insert during removal in accordance with an exemplaryembodiment of the invention;

FIG. 4A is a profile view of an incontinence device with an invertinginsert located in an applicator in accordance with an exemplaryembodiment of the invention;

FIG. 4B is a profile view of an incontinence device with an invertinginsert deployed in accordance with an exemplary embodiment of theinvention;

FIG. 4C is a profile view of an incontinence device with an invertinginsert during removal in an exemplary embodiment of the invention;

FIG. 5 is a profile view of an incontinence device with an integratedresilient support member in accordance with an exemplary embodiment ofthe invention;

FIG. 6 is a profile view of an incontinence device provided with tensionreducing arms in accordance with an exemplary embodiment of theinvention;

FIG. 7A is a profile view of a scrolling incontinence device inaccordance with an exemplary embodiment of the invention;

FIG. 7B is a profile view of a scrolling incontinence device with aflared proximal end in accordance with an exemplary embodiment of theinvention;

FIG. 7C is a top and/or bottom view of a scrolling incontinence devicein accordance with an exemplary embodiment of the invention;

FIG. 7D is a top view of a scrolling incontinence device in anapplicator in accordance with an exemplary embodiment of the invention;

FIG. 8 is a profile view of a connected, double-sided, scrollingincontinence device in accordance with an exemplary embodiment of theinvention;

FIG. 9A is a cross sectional view of an applicator with a lubricatingring in accordance with an exemplary embodiment of the invention;

FIG. 9B is a cross sectional view of an applicator with a removablecover in accordance with an exemplary embodiment of the invention;

FIG. 10A is side view of an applicator with a lubricating sleeve inaccordance with an exemplary embodiment of the invention;

FIG. 10B is a cross sectional view of an applicator with a lubricatingsleeve in accordance with an exemplary embodiment of the invention;

FIG. 11A is a cross sectional view of an applicator and a loosely loadedincontinence device in accordance with an exemplary embodiment of theinvention;

FIG. 11B is a cross sectional view of a flared proximal end applicatorloaded with an incontinence device in accordance with an exemplaryembodiment of the invention;

FIG. 12A is a side view of a slotted applicator with a sliding sleeve ina distal position in accordance with an exemplary embodiment of theinvention;

FIG. 12B is a side view of a slotted applicator with a sliding sleeveloaded with an incontinence device with arms protruding out of theapplicator slots in accordance with an exemplary embodiment of theinvention;

FIG. 12C is a cross sectional view of a slotted applicator with asliding sleeve loaded with an incontinence device in accordance with anexemplary embodiment of the invention;

FIG. 12D is a side view of a slotted applicator with a sliding sleevewherein a sliding sleeve is in a proximal position in accordance with anexemplary embodiment of the invention;

FIG. 13 is a cross sectional view of a telescoping plunger in accordancewith an exemplary embodiment of the invention;

FIG. 14A is a cutaway view of an applicator containing a bi-stableincontinence device within accordance with an exemplary embodiment ofthe invention;

FIG. 14B is a bi-stable incontinence device in a deployed configurationin accordance with an exemplary embodiment of the invention;

FIG. 15A is a cross-sectional view of an incontinence device with ano-ring insert, in accordance with an exemplary embodiment of theinvention;

FIG. 15B is a cross-sectional view of an incontinence device with ano-ring insert being removed, in accordance with an exemplary embodimentof the invention;

FIGS. 15C and 15D are top views of exemplary configurations of an o-ringinsert, in accordance with an exemplary embodiment of the invention;

FIG. 16A is a cross-sectional view of an incontinence device with aplurality of components removably fitted together in a storageconfiguration, in accordance with an exemplary embodiment of theinvention;

FIG. 16B is a cross-sectional view of an incontinence device with aplurality of components removably fitted together in a deployedconfiguration, in accordance with an exemplary embodiment of theinvention;

FIG. 16C is a cross-sectional view of an incontinence device with aplurality of components removably fitted together in a removalconfiguration, in accordance with an exemplary embodiment of theinvention;

FIG. 16D is a cross-sectional view of an alternative incontinence devicewith a plurality of components removably fitted together in a deployedconfiguration, in accordance with an exemplary embodiment of theinvention;

FIG. 17A is a cross-sectional view of an incontinence device with aplurality of components removably fitted together including an elasticcomponent in a storage configuration, in accordance with an exemplaryembodiment of the invention;

FIG. 17B is a cross-sectional view of an incontinence device with aplurality of components removably fitted together including an elasticcomponent in a deployed configuration, in accordance with an exemplaryembodiment of the invention;

FIG. 17C is a cross-sectional view of an incontinence device with aplurality of components removably fitted together including an elasticcomponent in a removal configuration, in accordance with an exemplaryembodiment of the invention;

FIG. 17D is a cross-sectional view of an alternative incontinence devicewith a plurality of components removably fitted together including anelastic component in a deployed configuration, in accordance with anexemplary embodiment of the invention;

FIG. 18A is a cross-sectional view of a deployed incontinence devicewhich uses an interlocking keystone insert, in accordance with anexemplary embodiment of the invention;

FIG. 18B is a cross-sectional view of an incontinence device which usesan interlocking keystone insert being removed, in accordance with anexemplary embodiment of the invention;

FIG. 19A is a cross-sectional view of an elasto-mechanically expandingincontinence device in a storage configuration, in accordance with anexemplary embodiment of the invention;

FIG. 19B is a cross-sectional view of an elasto-mechanically expandingincontinence device in a deployed configuration, in accordance with anexemplary embodiment of the invention;

FIG. 19C is a cross-sectional view of an elasto-mechanically expandingincontinence device in a removal configuration, in accordance with anexemplary embodiment of the invention;

FIG. 20A is a cross-sectional view of an incontinence device providedwith an elastomeric ring in a storage configuration, in accordance withan exemplary embodiment of the invention;

FIG. 20B is a cross-sectional view of an incontinence device providedwith an elastomeric ring in a deployed configuration, in accordance withan exemplary embodiment of the invention;

FIG. 20C is a cross-sectional view of an incontinence device providedwith an elastomeric ring in a removal configuration, in accordance withan exemplary embodiment of the invention;

FIG. 20D is a cross-sectional view of an alternative incontinence deviceprovided with an elastomeric ring in a deployed configuration, inaccordance with an exemplary embodiment of the invention;

FIG. 20E is a cross-sectional view of an alternative incontinence deviceprovided with an elastomeric ring in a removal configuration, inaccordance with an exemplary embodiment of the invention;

FIGS. 20F-I are cross-sectional views of alternative inserts which canbe used with incontinence devices described herein, in accordance withan exemplary embodiment of the invention;

FIG. 21A is a cross-sectional view of an incontinence device providedwith dimension setting connectors in a storage configuration, inaccordance with an exemplary embodiment of the invention;

FIG. 21B is a cross-sectional view of an incontinence device providedwith dimension setting connectors in a deployed configuration, inaccordance with an exemplary embodiment of the invention;

FIG. 22A is a cross-sectional view of an exemplary arm configuration, inaccordance with an exemplary embodiment of the invention;

FIG. 22B is an exemplary cross-sectional view of an incontinence device,in accordance with an exemplary embodiment of the invention;

FIG. 22C is a cross-sectional view of an exemplary arm configuration, inaccordance with an exemplary embodiment of the invention;

FIG. 23A is a cross-sectional view of an incontinence device providedwith a leaf spring support section, in accordance with an exemplaryembodiment of the invention;

FIG. 23B is a cross-sectional view of a deployed incontinence deviceprovided with a leaf spring support section, in accordance with anexemplary embodiment of the invention;

FIG. 24 is a cross-sectional view of an applicator with a lubricatinglayer, in accordance with an exemplary embodiment of the invention; and,

FIG. 25A is a cross-sectional view of a slotted applicator with asliding sleeve in a distal position in accordance with an exemplaryembodiment of the invention;

FIG. 25B is a cross-sectional view of a slotted applicator with asliding sleeve in a primed position in accordance with an exemplaryembodiment of the invention;

FIG. 25C is a cross-sectional view of a slotted applicator with asliding sleeve in an imminent deployment position in accordance with anexemplary embodiment of the invention;

FIG. 26A is a cross-sectional view of a collapsible applicator in acollapsed configuration, in accordance with an exemplary embodiment ofthe invention;

FIG. 26B is a cross-sectional view of a collapsible applicator in anexpanded configuration, in accordance with an exemplary embodiment ofthe invention;

FIG. 27A is a profile view of an incontinence device with an expandableinsert in a deployed configuration, in accordance with an exemplaryembodiment of the invention;

FIG. 27B is a profile view of an incontinence device with an expandableinsert in a removal configuration, in accordance with an exemplaryembodiment of the invention;

FIG. 28A is a profile view of an incontinence device with a ringedinsert in a storage configuration, in accordance with an exemplaryembodiment of the invention;

FIG. 28B is a profile view of an incontinence device with a ringedinsert in a deployed configuration, in accordance with an exemplaryembodiment of the invention; and,

FIG. 28C is a perspective view of a ringed insert, in accordance with anexemplary embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS Introduction

Referring to FIG. 1A, a profile view of an exemplary embodiment of theincontinence device 100 is shown. In an exemplary embodiment of theinvention, the device 100 is arranged around a central axis 150 anddivided into three parts. Optionally, the device has more or less parts.A top section 106 is provided which serves as the “anchoring” element,for stabilizing the device within the vagina. There are two types ofanchoring, axial anchoring which acts in the direction along the centralaxis of the vagina, and radial anchoring which acts side-to-side orsubstantially perpendicular to the central axis of the vagina. A bottomsection 110 is provided which serves as the “supporting” element, forgenerating urethral support. In some embodiments of the invention,support is generated at a mid-urethral location. In some embodiments ofthe invention, the bottom supporting section 110 provides at least oneform of anchoring to help anchor device 100 in position. In someembodiments of the invention, the entire length of device 100 is between30 mm and 50 mm. optionally, device 100 is larger or smaller dependingon the individual needs of the patient. In some exemplary embodiments ofthe invention, the various sections, parts and/or elements described areoptional. In some exemplary embodiments of the invention, the functionsthe various sections, parts and/or elements perform are optional.

In some exemplary embodiments, a central section 108, or node, isprovided which optionally connects anchoring 106 and supporting 110elements. The node 108 of this and many other devices described hereinhas a length which is only a small portion of the overall length of thedevice, in some embodiments of the invention. In some embodiments of theinvention, the length of the node is less than 15% of the entire lengthof the device. In some embodiments of the invention, the length of thenode is less than 20% of the entire length of the device. In otherembodiments of the invention, the length of the node is less than 30%the entire length of the device. In an exemplary embodiment of theinvention, the length of the overall device is up to 75 mm. Optionally,the length of the overall device is up to 60 mm. Optionally, the lengthof the overall device is 50 mm. In some exemplary embodiments of theinvention, the overall device is not less than 30 mm in length. In someembodiments of the invention, a node which is short relative to theentire length of the device allows for more flexibility in varying thestiffness, the comfort, and the size of device 100. Optionally, the nodeis not provided with one axis longer than the other, the axes are equalin length (e.g. a sphere or a cube). In an exemplary embodiment of theinvention, a small node in relation to the overall length of the deviceallows for greater control over the behavior of the anchoring andsupport arms, described below. This is because the overall length of thedevice is somewhat determined by the topography of the vagina. If, forexample, the central node was a significant portion of the overalllength of the device, then the arms would be short in length and at anangle to the central node close to 90°. This configuration does not havethe advantage of being able to take advantage of the flexibility that ispossible with longer arms at a lower angle of incidence to the centralnode.

In some exemplary embodiments of the invention, a cover 120, describedin more detail below, is provided to device 100. The elements of thedevice 100 optionally function as an internal support structure for acover 120. Optionally, the tension of cover 120 is increased by the armsof device 100.

In an exemplary embodiment, the anchoring element 106 and the supportingelement 110 have four (4) arms each or arm sets 112 and 114,respectively. In an exemplary embodiment of the invention, four arms areprovided to each section in which two are generally projected towardsthe bladder, and two are generally projected towards the vaginal flooradjacent the bowels. The two support arms which project towards thebladder fit within natural slots on either side of the urethra in someembodiments of the invention. Optionally, the anchoring and supportingelements are provided with more or less arms. For example, the anchoringelement could have more arms if there is concern about unwanted movementof device 100. In other embodiments of the invention, the arms areprovided at varied angles with respect to the node 108 and/or eachother. Optionally the arms 112 and 114 are flexible or rigid and areconstructed of a biocompatible material. Optionally, each of the armsreacts individually to the forces exerted on them by the vaginal wall,like independent suspension in an automobile. Optionally, each of thesupport arms functions separately to render support to the urethra.Optionally, padding elements adapted for contact are provided to thearms where they are likely to contact the vaginal wall of the user inorder to increase the contact surface area and thus, increase comfort tothe wearer. Padding elements also reduce the likelihood of necrosis dueto the reduced pressure exhibited between the device and the vaginalwall, as a result of the increase in contact surface area between thetwo. In an exemplary embodiment of the invention, the anchoring elementdoes not apply significant pressure to the wearer's vagina and/orurethra, thereby enhancing comfort.

In some embodiments of the invention, other structure is providedinstead of arms which is capable of supporting the urethra, in the caseof the support section, or preventing the device from unintentionallymoving, in the case of the anchor section. For example, at least onecone, protrusion, and/or extension attached to the node could be usedfor anchoring and support.

The anchoring arms of the device prevent the device from movingunintentionally out of position. In an exemplary embodiment of theinvention, the anchor element arms 112 resist motion of the devicetowards the uterus because the arms increase their angle to the node108. This effective increase in radius operates to counteract the motionof the device further into the vagina. In some embodiments of theinvention, anchor element arms 112 are provided with a large angle tothe node to enhance this anchoring effect. It should be noted that thisenhanced anchoring effect is observed only up until a maximum angle. Anarrowed node 108 increases the flexibility and the possible ranges ofmovement for the overall device 100 in some embodiments of theinvention. Optionally, devices such as wires and/or springs are embeddedin the neck in order to enhance flexibility for device 100. Thisadditional flexibility can enhance the comfort of the woman whilewearing the device 100. Optionally, the additional flexibility of device100 enables more comfortable defecation in comparison to prior artdevices. Any of the embodiments described herein are optionally utilizedin conjunction with a narrowed node 108.

While the arms are flexible, it should be noted that they are rigidenough to prevent unwanted motion of the device towards the entrance ofthe vagina. Optionally, the arms are rigid but the node is flexible, thenode thus providing flexible anchoring and support. Movement towards thevaginal opening is resisted by the arms which position themselves in thevagina towards the cervix and which, in some exemplary embodiments ofthe invention are held in place by pressure exerted on them by thevaginal wall, see for example the description of “tenting” below. Thesefeatures work independently from and in conjunction with the tentingbehavior of the vaginal walls described below, which also helps tomaintain the device in place.

An additional feature of the anchoring arms of the device 100 is thatthey operate remotely from the support arms. This reduces the amount ofpressure applied to the urethra by the device because in some exemplaryembodiments of the invention, the support arms do not need to renderanchoring functions in addition to support. Optionally, the urethralsupport is mid-urethral support. Such a configuration increases comfortto the wearer, prevents unnecessary damage to the tissues adjacent tothe device, increases the anchoring function of the device, and in someoptional embodiments of the invention allows the wearer to voidvoluntarily without having to remove the device to urinate.

The arms 112 of the anchoring element 106 force the device 100 to remainin situ within the vagina, unable to substantially move inwards oroutwards, or to rotate. One reason this occurs is as a result of thespecial tendency of vaginal walls to collapse and form an occludedlumen. The arms of the device cause “tenting” of the walls on top ofthem with resultant sagging of the walls around the node 108, therebystabilizing the device 100. The arms 114 of the supporting element 110cause relative elevation of the tissues around mid-urethra, acting as ahammock. This hammock supports mid-urethra in a tension free manner,much like the TVT operation. In a woman who leaks urine during astressful event (when abdominal pressure rises during coughing,sneezing, etc.), the urethra sags down but meets the hammock in its midpart. The meeting of the urethra and the hammock causes an elevation ofthe intra-urethral pressure with resultant urinary continence. In someembodiments of the invention the radiating support arms 114 of device100 create an overall device radial diameter of 25 mm to 50 mm withinthe vaginal cavity. Optionally, the diameter is larger or smallerdepending on the individual needs of the patient.

It should also be noted that for certain women, the described devicesherein can also be used as a treatment for prolapse. For example, armswhich are expanded to a certain radius for incontinence treatment canoptionally expand to a larger radius for prolapse treatment. Forexample, prolapse treating configurations optionally exhibit a diameterof up to 100 mm.

Various incontinence device embodiments are described herein, many ofwhich utilize inserts to assist with radial expansion of theincontinence device. It should be noted that many of these insertsoptionally have multiple stop positions which correspond to multipleincontinence device configurations. Specific positions are optionallyselected depending on the needs of the patient. In addition, althoughcertain nomenclature is used (e.g. “anchoring” and “support”) it shouldbe understood that these are for ease of reference only, and in someembodiments of the invention an “anchoring” section could be used forproviding urethral support and/or vice versa.

Exemplary Devices with an Insert for Treating Incontinence

In some exemplary embodiments of the invention, arms are manufactured sothat they are biased towards a central axis of device 100. In such anembodiment, it is expected that storage (e.g. storage in an applicator,such as described below) in a contracted configuration imposes lessstress on device 100 than if it was manufactured with arms biased in anexpanded configuration. The arms are optionally placed in an expandedconfiguration during or after deployment, such as by using the insertsdescribed herein. In an exemplary embodiment of the invention, it isconceived that removal of the insert causes the arms to return to thecontracted state for easy removal from the user's vagina. Many of theexemplary incontinence devices described herein are optionallymanufactured with anchoring and/or support elements (e.g. arms) beingbiased in a contracted, non-deployed configuration.

FIGS. 1A-B, 2A-D, 3A-C, 15A-D, 16A-D, 17A-D, 18A-B, 23A-B, 27A-B and28A-C show different exemplary embodiments of inserts which areoptionally used with an incontinence device. Inserts are generally usedto provide the support arms with additional support against pressureexerted on the support arms by the vaginal wall and/or with radialexpansion. In addition, removable inserts such as those describedherein, enable the incontinence devices to render effective incontinencetreatment while avoiding some of the storage stresses that wouldnormally come with devices which render such effective treatment.

In an exemplary embodiment of the invention, storage stresses areavoided because the insert is stored in a non-deployed position, thenon-deployed position not exerting treatment level pressure on thesupport arms. It should be understood, that the inserts and deviceconfigurations described in reference to FIGS. 1A-B, 2A-D, 3A-C, 15A-D,16A-D, 17A-D, 18A-B, 23A-B, 27A-B and 28A-C are exemplary only, and thatdifferent configurations are optionally used depending on the needs ofthe patient. For example, the insert is optionally shaped to urge thesupport arms to different radial expansion diameters, as measured from acentral axis of the device. Optionally, the insert is provided with aplurality of removably locking positions on the device, with eachlocking position corresponding to a slightly different configuration,such as radial expansion diameter, of the device.

In the exemplary embodiment of the invention depicted in FIG. 1A,incontinence device 100 is provided with a conical insert 118. Conicalinsert 118 is designed such that upon insertion into a conical recess122, located just proximal of node 108, conical insert 118 appliesoutward radial pressure to support arms 114, thereby causing them todiverge and support the urethra. Optionally, conical insert 118 isinserted into conical recess 122 upon deployment from an applicator, viapressure from a plunger. Optionally, conical insert 118 is prepositionedin conical recess 122 prior to deployment. Optionally, varying sizes ofconical insert 118 are used depending on the spread desired from supportarms 114.

In an exemplary embodiment of the invention, conical insert 118 oncedeployed into conical recess 122 is removably fixed there by frictionand/or pressure. Friction is created between the outer surface ofconical insert 118 and the surface facing conical insert 118 of conicalrecess 122. This friction resists movement of conical insert 118 fromconical recess 122, especially with the addition of pressure exerted onconical insert 118 by support arms 114. In an exemplary embodiment ofthe invention, pressure on conical insert 118 by support arms 114 isultimately derived from pressure on device 100 from the vaginal wall.

In some exemplary embodiments of the invention, conical insert 118 isconstructed from any material capable of urging support arms 114outward. Optionally, device 100 is positioned beneath the mid-urethra torender support. Optionally, any of the devices described herein rendermid-urethral support. Conical insert 118 is optionally constructed ofthe same material as device 100. Optionally, conical insert 118 isconstructed of a harder and/or stiffer and/or denser material thandevice 100 to provide enhanced resistance to the counter-pressure of thevaginal wall. In some exemplary embodiments of the invention, a removaldevice 116, such as a string, is attached to conical insert 118.

Referring to FIG. 1B, a profile view of incontinence device 100 withconical insert 118 is shown during device 100 removal, in accordancewith an exemplary embodiment of the invention. In some embodiments,application of a downward force, a force away from the cervix, dislodgesconical insert 118 from conical recess 122. Once the support rendered tosupport arms 114 is removed by removing conical insert 118, they aremore easily able to converge towards central axis 150 facilitatingeasier and/or more comfortable removal of device 100 than if the arms114 were fully deployed with conical insert 118 reinforcement.Optionally, conical insert 118 remains within cover 120 upon detachmentfrom conical recess 122. Optionally, additionally or alternatively, aremoval device is attached to cover 120 wherein upon a downward forceexercised on the removal device causes cover 120 to collapse on supportarms 114, forcing them towards central axis 150 and therefore reducingthe radial profile of device 100 for easier removal.

FIG. 2A shows a profile view of an incontinence device 200 with ageometric locking insert 202 in accordance with an exemplary embodimentof the invention. Device 200 is slightly different than device 100 inthat it is optionally comprised of more than one piece. The addition ofat least one additional piece allows for part of the insert to lock withdevice 200, and for part of the insert to be removable to assist withdevice 200 removal. In addition, in some exemplary embodiments of theinvention, an external ring 206 of device 200 is capable of mechanicallylocking into the support arms. Device 200 is shown in an applicator 204which can optionally be used to deploy device 200 in the vagina. In someexemplary embodiments of the invention, device 200 is comprised of aplurality of components. Optionally, external ring 206 is provided whichis adapted to be locked into a slot 208 located on the inner surfaces ofsupport arms 210. Optionally, a plurality of slots are located on theinner surfaces of support arms 210, external ring 206 being pushed fromslot to slot until the desired radial expansion of support arms 210 isachieved. Optionally, there is provided an internal insert 212 adaptedto geometrically mate with the inner surface of external ring 206 suchthat internal insert 212 can be inserted through external ring 206.Optionally, more than external ring 206 and internal insert 212 comprisegeometric locking insert 202. Optionally, a connecting device 214 isprovided which maintains internal insert 212 in close proximity toexternal ring 206 in a suitable orientation for insertion of internalinsert 212 through external ring 206.

In an exemplary embodiment of the invention, device 200 is stored inapplicator 204 in a partially assembled state, such as shown in FIG. 2A.In some exemplary embodiments of the invention, maintaining device 200in a partially assembled state, particularly where external ring 206 isnot locked into slot 208, the device adapted to better withstand storagestresses while not in use, allowing for longer storage and/or greaterefficacy of device 200. Deployment of device 200 is illustrated in FIG.2B where internal insert 212 is urged through external ring 206 by aplunger 216 (depicted in FIG. 2A), in an exemplary embodiment of theinvention. Upon the engagement of external ring 206 by internal insert212, external ring 206 is urged towards slot 208 by continued pressuretowards the cervix on plunger 216. Device 200 eventually locks itself inslot 208, which in turn urges support arms 210 radially outwards into adeployed position thereby exerting a predefined supportive tension, inan exemplary embodiment of the invention.

FIG. 2C illustrates device 200 in a deployed mode according to anexemplary embodiment of the invention. It can be seen that external ring206 is locked into slot 208, which is shaped to mate with apredetermined external ring profile. Optionally, multiple slots areprovided which are capable of receiving external ring 206, with eachslot defining a different configuration for device 200. Optionally,external ring 206 is shaped to avoid misapplication, for example withgrooves to accommodate support arms 210. Internal insert 212 isremovably positioned within external ring 206. Optionally, internalinsert 212 is held in place by frictional forces between external ring206 and internal insert 212. Optionally, internal insert 212 is held inplace by compression forces from support arms 210.

FIG. 2D is a profile view of device 200 showing removal of device 200,in accordance with an exemplary embodiment of the invention. Removal ofdevice 200 is optionally achieved by pulling on removal device 218 awayfrom the cervix. Optionally, removal device 218 is attached to internalinsert 212. Additionally or optionally, removal device 218 is attachedto device 200. Sufficient force on removal device 218 in a directionaway from the cervix dislodges internal insert 212 from external ring206, in accordance with an exemplary embodiment of the invention. In anexemplary embodiment of the invention, sufficient force is such that itis enough to remove internal insert 212 from its friction fit toexternal ring 206, accounting for at the very least the pressurerendered to internal insert 212 from the vaginal wall via device 200 andexternal ring 206. Once the at least partially flexible external ring206 is no longer reinforced by internal insert 212, support arms 210 areallowed to converge towards the central axis of device 200 enablingeasier and/or more comfortable removal of device 200. Optionally, acover is used in conjunction with device 200. In an exemplary embodimentof the invention, the cover may also contribute to converging supportarms 210 towards the central axis during removal. Optionally, a removaldevice is attached to the cover.

Referring to FIG. 3A, an incontinence device 300 with a varying geometryinsert 302 is shown, in accordance with an exemplary embodiment of theinvention. In some exemplary embodiments of the invention, device 300 isdifferent from device 100 and device 200 in that varying geometry insert302 traverses the length of the central node of device 300, as opposedto staying essentially within the confines of the support section.Varying geometry is provided to insert 302 in order to perform at leastthree basic functions with respect to device 300. First, the distalprotrusion is used to prevent insert 302 from being pulled out of device300 from the proximal side of device 300, in an exemplary embodiment ofthe invention. Second, a locking protrusion 316 is used to secure insert302 to device 300 when in a deployed condition, in accordance with anexemplary embodiment of the invention. Third, a support protrusion isused to provide support to the support arms of device 300 in accordancewith an exemplary embodiment of the invention.

In an exemplary embodiment of the invention, device 300 is depicted inan applicator 304 adapted for deployment of the device 300 into a vaginato render urethral support. Optionally, urethral support includesmid-urethral support. Optionally, device 300 is used in conjunction witha cover 306. In an exemplary embodiment of the invention, a plunger 308is provided to proximal end of applicator 304 to facilitate deploymentof device 300, where proximal end is towards the vaginal opening anddistal is towards the cervix. Optionally, only two distinct protrusionsare present. In an exemplary embodiment of the invention, at the distalend of insert 302 is a distal protrusion 310 located in a recess locatedat the convergence of the anchoring arms 312. Optionally, distalprotrusion 310 is adapted and constructed to resist, optionally prevent,passage of the entire insert 302 away from the cervix through a canal314 which passes through device 300 and which accommodates insert 302. Alocking protrusion 316 is optionally located between the distal andproximal ends of insert 302 and is shaped, in accordance with someexemplary embodiments of the invention, to mate with a locking recess318 located in canal 314. A support protrusion 320 is located at theproximal end of insert 302 in an exemplary embodiment of the invention.In some exemplary embodiments of the invention, device 300 is a devicewith multiple stable configurations, such as described below.

FIG. 3B illustrates incontinence device 300 in an exemplary deployedconfiguration, wherein insert 302 is advanced through canal 314 suchthat locking protrusion 316 is removably locked in locking recess 318.In some exemplary embodiments of the invention, locking protrusion 316and/or locking recess 318 are positioned sufficiently away from supportprotrusion 320 such that when in a removably locked condition, supportprotrusion 320 is in a position to render reinforcement to support arms322. In an exemplary embodiment of the invention, support protrusion 320urges support arms 322 radially outwards into a predefined position,optionally depending on the shape of support protrusion 320. Optionally,support arms 322 support the mid-urethra.

Removal of device 300 is optionally accomplished by unlocking insert 302from locking recess 318 and dislodging supporting protrusion from itsdeployed position at the convergence of support arms 322. Optionally,removal of incontinence device 300 is effectuated by pulling on aremoval device 324, depicted in FIG. 3C away 326 from the cervix. In anexemplary embodiment of the invention, sufficient applied force toremoval device 324 causes locking protrusion 316 to become dislodgedfrom locking recess 318, unlocking locking protrusion 316 and permittingmovement of insert 302 towards the vaginal opening. In an exemplaryembodiment of the invention, distal protrusion 310 halts downward motionof insert 302 when it reaches the recess marking the convergence ofanchoring arms 312 because it is sized larger than canal 314. Continueddownward force on removal device 324 causes device 300 to be removedfrom vagina as removal device 324 is attached to insert 302 which is notremovable from device 300. Optionally or additionally, a removal device324 is attached to cover 306. Optionally, removal is assisted by cover306 which urges support arms 322 towards the central axis of device 300,allowing for easier and/or more comfortable removal.

Referring to FIG. 15A, a deployed incontinence device 1500 is shownwhich is provided with an o-ring shaped insert 1502, examples of whichare shown in more detail in FIGS. 15C and D, in accordance with anexemplary embodiment of the invention. In some exemplary embodiments ofthe invention, o-ring insert 1502 is removably positioned in at leastone groove 1504 located on a surface, shown more clearly in FIG. 15B, ofthe support arms 1506 located opposite the vaginal wall and adapted toreceive o-ring insert 1502 and removably hold insert 1502 there duringuse of incontinence device 1500. While in use, support arms 1506 ofincontinence device 1500 are urged radially outwards by o-ring insert1502 to render support to a urethra. Optionally, the mid-urethra issupported by support arms 1506. In some exemplary embodiments of theinvention, incontinence device 1500 is provided with a cover 1508, whichfunctions similarly to other covers described herein. In some exemplaryembodiments of the invention, o-ring insert 1502 is not located ingroove 1504 prior to deployment of incontinence device 1500 into avagina, and is placed there during deployment using, for example, aplunger such as described with respect to other embodiments.

FIG. 15B shows a cross-sectional view of incontinence device 1500 duringremoval, in accordance with an exemplary embodiment of the invention. Inorder to facilitate removal of incontinence device 1500, in someexemplary embodiments of the invention, a removal device 1510 is used todislodge o-ring insert 1502 from groove 1504. Removal device 1510 isattached to o-ring insert 1502 and is also optionally attached toincontinence device 1500 to enable removal device 1510 to assist withextraction of incontinence device 1500 from the vagina in which it isbeing used and/or to prevent loose objects from floating around insidethe user's body. In some exemplary embodiments of the invention, removaldevice 1510 is secured to incontinence device 1500 by threading aportion of removal device 1510 through the central node of incontinencedevice. In some exemplary embodiments of the invention, an enlargedportion 1512 is used to prevent removal device 1510 from pulling throughthe central node during removal. Force exerted on removal device 1510 ina direction away from the cervix of the user will result in dislodgmentof o-ring insert 1502 from device 1500 and eventually incontinencedevice 1500 as a whole from vagina, in some exemplary embodiments of theinvention.

In some exemplary embodiments of the invention, an insert 1602 which isat least partially elastic is provided to an incontinence device 1600,such as shown in FIG. 16A. FIG. 16A shows incontinence device 1600 in astorage configuration, for example if device 1600 was in an applicator.In the storage configuration, elastic insert component 1604 is stretchedsuch that it is longer than the device 1600, such as shown in FIG. 16A.In such a configuration, the flared nature of insert 1602 does notsignificantly cause radial expansion of support 1608 and/or anchor arms1610 of device 1600, such as shown in FIG. 16B. This is primarily due tostretchable nature of elastic insert component 1604 allowing insert 1602to remain outside the realm of support 1608 and/or anchor arms 1610 ofdevice 1600.

In some exemplary embodiments of the invention, insert 1602 is comprisedof a plurality of component parts, for example elastic insert component1604 and an addition inner insert component 1606. In some exemplaryembodiments of the invention, inner insert component 1606 is adapted toremovably mate with elastic insert component 1604. Optionally, innerinsert component 1606 exhibits different material properties thanelastic insert component 1604, for reasons described below. In anexemplary embodiment of the invention, an elastic insert component 1604and an inner insert component 1606 are used in combination to provideradial expansion during deployment to support arms 1608 and anchor arms1610 of the incontinence device 1600. In some exemplary embodiments ofthe invention, inner insert component 1606 is attached to elastic insertcomponent 1604 with a string, which penetrates the length of elasticinsert component 1604 and which is secured to elastic insert component1604 with an expanded end 1612 at the anchoring side of device 1600.Optionally, expanded end 1612 is a knot formed by knotting and/ormelting the string. It should be noted that in some exemplaryembodiments of the invention the string has to be long enough to allowthe stretching of elastic insert component 1604, which cups inner insertcomponent 1606, to be longer than device 1600.

Referring to FIG. 16B, incontinence device 1600 is shown in a deployedconfiguration, in accordance with an exemplary embodiment of theinvention. Upon deployment of device 1600 out of an applicator, thesupport 1608 and anchor 1610 arms are free to expand radially. In anexemplary embodiment of the invention, this freedom of movement issufficient to allow the stretched insert 1602 to return to its nominalstate. Insert 1602 unstretches causing a flared anchor end 1614 ofelastic insert component 1604 to force anchor arms 1610 radiallyoutwards and flared inner insert component 1606, cupped within elasticinsert component 1604, to force support arms 1608 radially outwards asthey collapse in towards the center of device 1600. In some exemplaryembodiments of the invention, inner insert component 1606 is held withinelastic insert component 1604 by friction between the two components. Insome exemplary embodiments of the invention, elastic insert component1604 is provided with a slight lip around its opening which helps retaininner insert component 1606 within elastic insert component 1604. Insuch an embodiment, the lip is not sufficient to withstand removalforces exerted on inner insert component 1606, as described below,thereby releasing inner insert component 1606 and allowing device 1600removal.

FIG. 16C shows an exemplary removal configuration of incontinence device1600, in accordance with an exemplary embodiment of the invention. Innerinsert component 1606 is optionally dislodged by pulling on a removaldevice 1616 in order to facilitate device 1600 removal, in someexemplary embodiments of the invention. Dislodgment of inner insertcomponent 1606 reduces the outward radial force exerted on support arms1608 allowing support arms 1608 to return to a nominal, less expandedstate for easier removal. In some exemplary embodiments of theinvention, support arms 1608 squeeze elastic insert component 1604,causing it to deform, when support arms 1608 return to their nominalstate. As with other incontinence devices described herein, force onremoval device 1616 away from the cervix of the user causes inner insertcomponent 1606 to dislodge and continued force ultimately removes device1600 from the vagina. In some exemplary embodiments of the invention,device 1600 is provided with a cover 1618.

In an alternative embodiment, depicted in FIG. 16D, incontinence device1600 is provided with a jointed central node. Optionally, the interfaceat the joint is like a ball joint. In some exemplary embodiments of theinvention, the jointed nature of the central node results in an anchorsection 1620 and a support section 1622 of device 1600 being able tomove somewhat independently as a result of stresses being applied tothem by movement of the wearer. In some exemplary embodiments of theinvention, support section 1622 and anchor section 1620 are held in afriction causing relationship by elastic insert component 1604.

It should be noted that in some exemplary embodiments of the invention,such as those shown in FIGS. 16 and 17, at least part of theincontinence device is comprised of more than one material. Optionally,the insert is comprised of more than one material. In some exemplaryembodiments of the invention, the insert is made of a first materialwhich is at least partially flexible and/or a second material which isrigid enough to expand the support section of the incontinence devicewhen in the proper position to do so. In some exemplary embodiments ofthe invention, the insert is at least more rigid than the supportsection of the incontinence device. In an exemplary embodiment of theinvention, the first material is used for the elastic insert component1604 and/or the second material is used for the inner insert component1606. Selection of various materials is optionally made based on theobjectives for operation of the incontinence device. For example, a morerigid material is optionally used for elastic insert component 1604 ifupon removal of inner insert component 1606 it is desired that thesupport section still remains at least partially expanded. Optionally, aless rigid material is used for inner insert component 1606 if it isdesirable to increase the comfort to the wearer and/or reduce the degreeof radial expansion of the device.

Referring to FIGS. 17A-C, an incontinence device 1700 is shown whichalso has an insert 1702 which is essentially a plurality of componentsremovably fitted together. A difference between the incontinence device1700 depicted in FIG. 17 and the incontinence device 1600 depicted inFIG. 16 is the anchor end 1704 of insert 1702 is not flared to causeradial expansion of the anchor arms 1706. In an exemplary embodiment ofthe invention, because anchor end 1704 of insert 1702 is not flared, itdoes not have to be outside of anchor arms 1706 during storage, which isreflected in the embodiment depicted in FIG. 17A. It can be seen that instorage, anchor end 1704 of insert 1702 does not exert radial expansionforce on anchor arms 1706. FIG. 17B shows incontinence device 1700during deployment and FIG. 17C shows device 1700 during removal. Device1700 is optionally provided with a cover 1714. Besides providing anembodiment in which anchor arms 1706 are not radially expanded, storagestress on insert 1702 is reduced in relation to the embodiment depictedin FIGS. 16A-D because insert 1702 does not need to be stretched as farfor the same sized device when in storage. In addition, upon deployment,only one side of insert 1702 needs to unstretch in order to cause radialexpansion as opposed to two sides of insert 1602 (anchor and support) asshown in FIGS. 16A-D, avoiding a two stage deployment (first the anchorarms as they become free of applicator, then support arms) of device1700.

An alternate embodiment of incontinence device 1700 in which the supportarms 1708 are configured to accommodate the elastic insert component1710 cupping the inner insert component 1712 without them having to beoutside support arms 1708 during storage, is shown in FIG. 17D. In someexemplary embodiments of the invention, this allows a shorter stringconnecting inner insert component 1712 to elastic insert component 1710,and also allows for a shorter elastic insert component 1710.

Referring to FIG. 18A, an incontinence device 1800 is shown which isprovided with an insert seat 1802 adapted to removably receive an insert1804, in accordance with an exemplary embodiment of the invention.Optionally, insert seat 1802 connects an anchoring section 1806 and asupport section 1808 of incontinence device 1800 together. In anexemplary embodiment of the invention, insert 1804 is flared to provideradial expansion to insert seat 1802 and/or support section 1808 wheninsert 1804 is fitted into insert seat 1802. An integrated resilientsupport member 1820, described in more detail below with respect to FIG.5, is shown in use with incontinence device 1800. It can be seen fromFIG. 18B that in some exemplary embodiments of the invention, integratedresilient support member 1820 is adapted to cause radial expansion ofsupport section 1808 when insert 1804 is fitted into insert seat 1802.The flared sides of insert 1804 exert pressure on the exposed ends ofintegrated resilient support member 1820 forcing it radially outwards,and thus support section 1808 and/or a support arm 1816 radiallyoutwards. In an exemplary embodiment of the invention, the slope of theflared ends, and optionally their length, determines the quantity ofthis effect.

While FIG. 18A shows incontinence device 1800 in a deployedconfiguration, it should be understood that optionally insert 1804 isoptionally not fitted to insert seat 1802 while in storage. For example,insert 1804 is pushed into a position fitted to insert seat 1804 by aplunger, such as described elsewhere herein, during deployment from anapplicator.

FIG. 18B shows incontinence device 1800 in a removal configuration, inaccordance with an exemplary embodiment of the invention. In someexemplary embodiments of the invention, incontinence device 1800 isprovided with a removal device 1812. Sufficient force applied on removaldevice 1812 pulling away from the user's cervix causes insert 1804 todislodge from insert seat 1802, thereby removing the source of increasedradial expansion of support section 1808 and easing the removal ofdevice 1800. Optionally, pulling on removal device 1812 causes acollapse of at least support section 1808 and/or seat 1802 of device.Optionally, seat 1802 is predisposed to collapse inwards towards acentral axis of device 1800. Force away from the user's cervix issustained in order to pull device 1800 out of the user's vagina. Anexpanded end 1814 of removal device 1812 is used to prevent removaldevice 1812 from being pulled out of incontinence device 1800 duringremoval and also to prevent separation of insert 1804 from the rest ofdevice 1800. In some exemplary embodiments of the invention, device 1800is provided with a cover 1810, 1822.

Referring to FIG. 23A, an incontinence device 2300 is shown which isprovided with a resilient, biased support section in accordance with anexemplary embodiment of the invention. Device 2300 is comprised of atleast an anchoring section 2302, a support section 2304 and an insert2306, in an embodiment of the invention. Optionally, device 2300includes a central node, providing an intersection and/or bridgingstructure between anchoring section 2302 and support section 2304. Insome exemplary embodiments of the invention, support section 2304 iscomprised of a plurality of arms 2310, two of which are shown in FIGS.23A-B. In an exemplary embodiment of the invention, anchoring section2302 is formed of a biocompatible material and operates similar to otheranchoring sections described herein. Anchoring section 2302 is attachedto support section 2304, for example using a tucker 2308 as shown inFIG. 23A.

In an exemplary embodiment of the invention, support section 2304 isformed such that it maintains a nominal compressed configuration (whichis biased towards a central axis of device 2300), but is flexible enoughto be placed into an expanded configuration by insert 2306 (as shown inFIG. 23B). In some exemplary embodiments of the invention, supportsection 2304 applies a modicum of support when in the compressedconfiguration. Optionally, support section 2304 is a leaf spring whichis biased towards a central axis of device 2300. Optionally, supportsection 2304 is formed with an integrated resilient support member, suchas shown in FIG. 5. Optionally, support section 2304 is comprised ofmetal. Alternatively or additionally, support section 2304 is comprisedof plastic. In an exemplary embodiment of the invention, the ends ofarms 2310 are capped with a biocompatible material in order to provideenhanced comfort to the user. Optionally, the material capping arms 2310is flexible, such as rubber or plastic. In some embodiments of theinvention, insert 2306 is capable of use with a device 2300 with onlytwo support section 2304 arms 2310.

In operation, insert 2306 is forced upwards towards tucker 2308 with aplunger (not shown). Continued pressure using the plunger in thisdirection causes device 2300 to eventually deploy out of an applicator(not shown), assuming the deployed position depicted in FIG. 23B. FIG.23B shows insert 2306 within support section 2304 which is flexed atflex points 2312 during the positioning of insert 2306 therein.Reconfiguration of support section 2304 to render support is a result ofthe positioning of insert 2306 within in an exemplary embodiment of theinvention. In an exemplary embodiment of the invention, insert 2306 ismaintained within support section 2304 by the compressive force appliedto it by the biased support section 2304. In an embodiment of theinvention, removal of device 2300 is via downward force on removaldevice 2314 away from cervix and towards the vaginal opening. Insert2306 is dislodged from support section 2304 by this force on removaldevice 2314 allowing arms 2310 to contract to the compressedconfiguration and permitting comfortable removal of device 2300. In anembodiment of the invention, device 2300 is provided with a cover 2316similar to those described elsewhere herein.

Referring to FIG. 27A, an incontinence device 2700 is depicted with anexpandable insert 2702, in accordance with an exemplary embodiment ofthe invention. Device 2700 is shown deployed, for example as it would bein a user's vagina. An insert head 2706 is expanded by an insertexpander 2704 in a deployed configuration and in a removal configurationinsert head 2706 is contracted, or contracts of its own volition, by theremoval of insert expander 2704, in accordance with an exemplaryembodiment of the invention. In an exemplary deployed configuration,insert expander 2704 is positioned within a slot in insert head 2706. Insome embodiments of the invention, insert head 2706 is expanded byinsert expander 2704, causing insert head 2706 to exert pressure onsupport arms 2708 of device 2700. In an embodiment of the invention, thepressure exerted by insert head 2706, as a result of insert expander2704, causes radial expansion of support arms 2708 and subsequentlytreatment for incontinence. In an exemplary embodiment of the invention,insert expander 2704 is not positioned in insert head 2706 duringstorage. Optionally, insert head 2706 is flexible. In an exemplaryembodiment of the invention, expandable insert 2702 has an expandedportion which prevents expandable insert 2702 from being pulled throughdevice 2700 during removal, as shown in FIG. 27B.

FIG. 27B shows incontinence device 2700 in a removal configuration, inaccordance with an exemplary embodiment of the invention. Removal isinitiated by pulling on removal device 2710 which dislodges insertexpander 2704 from insert head 2706, in some exemplary embodiments ofthe invention. Upon the dislodgment of insert expander 2704 from inserthead 2706, insert head 2706 substantially releases the force exerted onsupport arms 2708, allowing them to contract, or at the minimum makingthem less resistant to collapsing towards a cerntral axis of device2700, for easier and more comfortable removal of device 2700. In anembodiment of the invention, device 2700 is used with a cover 2712 whichis provided with an opening which is sized such that removal device 2710can pass, but not insert expander 2704, due to the larger size of insertexpander 2704. Continued downward force on removal device 2710 away fromcervix and towards the vaginal opening will eventually cause insertexpander 2704 to catch on cover 2712 near the opening (since it cannotpass through the opening) and pull device 2700 out of the vagina. Asdescribed elsewhere herein, force applied on cover 2712 using removaldevice 2710 also assists the contraction of support arms 2708 easingremoval of device 2700.

Referring to FIG. 28A, an incontinence device 2800 with a ringed insert2802 is shown in a storage configuration, in accordance with anexemplary embodiment of the invention. An exemplary ringed insert 2802can be seen in perspective in FIG. 28C. Support arms 2806 of the devicepass through openings 2850 between the ring and the central portion ofringed insert 2802, in accordance with an exemplary embodiment of theinvention. In some embodiments of the invention, ringed insert 2802 isnot positioned within device 2800 while device 2800 is in storage,extending life and improving performance. In an exemplary embodiment ofthe invention, a removal/activator device 2812 is fastened to aremoval/activation plate 2814 located distally from a central portion ofdevice 2800.

In an exemplary embodiment of the invention, deployment of device 2800is commenced by pulling down on removal/activator device 2812, causingdevice 2800 to move towards the proximal end of the applicator 2808, andaffecting a pulling of the ringed insert 2802 into incontinence device2800. In an exemplary embodiment of the invention, activation ledges2816 are provided to applicator 2808 to provide a counter-force to thepulling of device 2800 onto insert 2802. Optionally, plunger 2804 isused to force insert 2802 into device 2800 to apply radial expansionforce to the support arms 2806, which will assume their deployedconfiguration upon device 2800 ejection from applicator 2808. Deploymentout of applicator 2808 and into vagina is performed as described withrespect to other embodiments herein.

An exemplary deployed configuration of device 2800 is shown in FIG. 28B.In an embodiment of the invention, ringed insert 2802 is positionedthrough device 2800 such that an insert head 2810 is located at thedistal side of device 2800. Optionally, insert head 2810 is shaped, forexample like an arrow-head, to allow its passage through device 2800during deployment, but to prevent passage of insert 2802 back throughdevice 2800, to the original configuration, thereafter. In an exemplaryembodiment of the invention, in a deployed configuration ringed insert2802 applies force to support arms 2806 causing them to expand radiallyoutwards. Optionally, device 2800 is provided with removal/activatordevice 2812, which, in addition to activating the incontinence device2800, can be used like other removal devices described herein.Optionally, device 2800 is provided with a cover.

Exemplary Devices with Multiple Stable Configurations for TreatingIncontinence

In some exemplary embodiments of the invention, incontinence devices areprovided with multiple stable configurations for treating incontinence.Optionally, a bi-stable component is used to provide incontinencedevices with a first stable position, for storage and/or removal, and asecond stable position, for rendering incontinence treatment. As usedherein, the bi-stable component is sometimes referred to as an insert, alocking element and/or an elastomeric ring. FIGS. 4A-C and 14A-B showexemplary embodiments of bi-stable inserts used with incontinencedevices which do not substantially move in relation to the incontinencedevice in order to transfer from the first stable position to thesecond. FIGS. 3A-C, above, and FIGS. 20A-C, described below in anothersection, show an exemplary embodiment of a bi-stable device where thebi-stable component moves in relation to the incontinence device whentransferring from the first stable position to the second stableposition. It should also be noted that in an exemplary embodiment of theinvention, deployment of the bi-stable devices occurs after the devicesare properly positioned within the vagina, “popping” into their secondstable position when the bi-stable insert is switched to the secondposition. In an exemplary embodiment of the invention, poppingdeployment is more comfortable than other forms of deployment describedherein because the support arms do not exert pressure against thevaginal wall until the incontinence device is already in a position torender incontinence treatment.

FIG. 4A is a profile view of an incontinence device 400 with aninverting, bi-stable insert 402 located in an applicator 406 inaccordance with an exemplary embodiment of the invention. Invertinginsert 402 resembles a flexible bowl-shaped membrane, in an exemplaryembodiment of the invention. Insert 402 is constructed such that whenmembrane is biased towards the proximal end of device 400 in a firstconfiguration, insert 402 membrane is flaccid. However, when themembrane is pushed through the center of insert 402 towards the distalend of device 400, the insert 402 membrane exerts radially expandingpressure on the support arms 404 of device 400 and the arms 404 “pop”into position. In an exemplary embodiment of the invention, insert 402membrane has variable wall width, and therefore, different tension atevery point. Optionally, insert 402 is located between support arms 404of device 400. Optionally, insert membrane 402 is pushed through its owncenter, thereby deploying device 400 into a second configuration, by aplunger 408 located at the proximal end of applicator 406.

FIG. 4B is a profile view of incontinence device 400 with an invertinginsert 402 deployed, in accordance with an exemplary embodiment of theinvention. It can be seen in this exemplary embodiment that duringdeployment plunger 408 pushed insert 402 membrane through its center,biasing it towards the distal end of device 400. As described herein,the membrane is constructed so that when it is biased towards theproximal end of device 400 it is flaccid, and when it is biased towardsthe distal end of device 400 it is sufficiently rigid to apply radialpressure to support arms 404 causing them to increase their diameter forurethral support. Optionally, the urethral support is mid-urethral.

Removal of device 400 is depicted in FIG. 4C, which shows a profile viewof incontinence device 400 with an optional removal device 410, such asa string. Force on removal device 410 in a proximal direction, away fromthe cervix, causes insert 402 membrane to re-invert transformingmembrane from at least semi-rigid to flaccid. The reduced radialpressure exerted by insert 402 membrane facilitates the movement ofsupport arms 404 towards the central axis of device 400 for easierremoval. In some exemplary embodiments of the invention, continued forceon removal device 410 pulls support arms 404 towards the central axis ofdevice 400 and towards the vaginal opening. Additionally, alternativelyor optionally, removal device 410 is fastened to a cover 412 which, whendownward force is applied to removal device 410, exerts pressure onsupport arms 404 towards the central axis of device 400 for easierremoval. The embodiment depicted in FIGS. 4A-C is optionally used withan integrated resilient support, as described below with respect to FIG.5.

Referring to FIG. 14A, a cutaway view of an applicator 1402 is shown,depicting a bi-stable incontinence device 1400 therein, in accordancewith an exemplary embodiment of the invention. The bi-stable insert ofFIGS. 14A-B is different from that of FIGS. 4A-C in that rather thanusing a membrane which exhibits first and second stable positionsdepending on its bias, mechanical arms are provided which exhibit firstand second stable positions. As described with respect to otherincontinence device embodiments herein, bi-stable incontinence device1400 is configured in a reduced diameter form for storage withinapplicator 1402. Applicator 1402 is, optionally, similar to any of theapplicators described herein and in related applications, known to thoseskilled in the art or not yet invented. In an exemplary embodiment ofthe invention, bi-stable incontinence device 1400 is provided with abi-stable locking element 1408 which is attached to a support armreinforcing element 1406. Bi-stable locking element 1408 is optionallyconfigured such that in a first stable position, wherein the bi-stablelocking element 1408 is biased towards support arms 1404 of device 1400,bi-stable locking element 1408 does not substantially urge support armreinforcing element 1406 radially outwards. However, in a second stableposition, wherein bi-stable locking element 1408 is biased towards theanchoring arms 1420, shown in FIG. 14B, of device 1400, bi-stablelocking element 1408 applies force to support arm reinforcing element1406 causing support arms 1404 to urge radially outwards from a centralaxis of incontinence device 1400. In some exemplary embodiments of theinvention, a plurality of reinforcing arms are attached to the supportarms 1404 of incontinence device 1400 such that when bi-stable lockingelement 1408 is in the second stable position reinforcing arms urgesupport arms 1404 radially outward from a central axis of device 1400.Optionally, each support arm 1404 is provided with a reinforcing arm.Optionally, selected support arms 1404 are supplied with reinforcingarms, for example if forced deployment of support arms 1404 is onlydesired along a single axis.

In some exemplary embodiments of the invention, support arm reinforcingelement 1406 has a central portion with a male locking cylinder 1416.Optionally, bi-stable locking element 1408 is provided with a centralfemale locking cylinder receiver, which allows for bi-stable lockingelement 1408 to be removably fastened to support arm reinforcing element1406. Removably fastening bi-stable locking element to support armreinforcing element counters pressure from the vaginal wall which actsto force device 1400 into the first stable position. Optionally, lockingcylinder 1416 is provided with a lip which is sized slightly larger thanan inner circumference of the locking cylinder receiver, which isoptionally a hole located on bi-stable locking element, such then whenlocking cylinder 1416 is urged against locking cylinder 1416 withsufficient force the receiver passes over the lip and becomes removablyfastened to support arm reinforcing element 1406. Optionally, bi-stablelocking element 1408 is biased such that when urged towards support armreinforcing element 1406, bi-stable locking element 1408 removably locksinto a reinforcing position without the need for lockably mating lockingcylinder 1416 with locking cylinder receiver. In some exemplaryembodiments of the invention, bi-stable locking element 1408 is urgedtowards support arm reinforcing element 1406 by a plunger 1410.Optionally, the anchoring force provided by anchoring arms 1420 is morethan the force required to switch support arm reinforcing element 1406from the first stable position to the second stable position such thatupon the insertion of device 1400 into the vagina, when anchoring arms1420 are in position, they prevent device 1400 from moving towards thecervix as pressure to “pop” into the second stable position is exertedon support arm reinforcing element 1406 by plunger. Optionally,incontinence device 1400 is provided with a removal device 1412 which isattached to bi-stable locking element 1408 such that it can change theposition of bi-stable locking element 1408 from the second stableposition to the first stable position.

Referring to FIG. 14B, bi-stable incontinence device 1400 is showndeployed in the second stable position, in accordance with an exemplaryembodiment of the invention. It can be seen that bi-stable lockingelement 1408 is urged against support arm reinforcing element 1406,urging the reinforcing arms radially outwards, and hence support arms1404 radially outwards from a central axis of device 1400. In anexemplary embodiment of the invention, support arms 1404 provide supportto a urethra. Optionally, the support is mid-urethral support.Optionally, device 1400 is used in conjunction with a cover 1418, suchas those described herein. Removal of device 1400 is optionallyfacilitated by exerting a downward force on removal device 1412 towardsa vaginal opening. This downward force causes bi-stable locking element1408 to change from the second stable position to the first stableposition, removing reinforcement from support arms 1404 and allowingthem to converge on a central axis of device 1400. The reduction inradial diameter of device 1400 due to this convergence enables an easierand/or more comfortable removal than if support arms 1404 had remaineddeployed.

In an exemplary embodiment of the invention, bi-stable locking element1408 is provided with reinforcing arms and the central portion ofsupport arm reinforcing element 1406 is omitted.

Exemplary Elastomeric Ring Incontinence Devices

Some of the embodiments described in this section are provided withmultiple stable configurations, for example those depicted in FIGS.20A-C. In some exemplary embodiments of the invention, an elastomericring 2002 is used to provide an incontinence device 2000 with radialexpansion and/or contraction, depending on whether ring 2002 is in thefirst stable position or the second stable position. Optionally, radialexpansion and/or contraction is caused by material properties and/orconfiguration of an incontinence device and a ring is selectivelypositioned to prevent specific configurations from manifestingthemselves. Referring to FIG. 20A, incontinence device 2000 is shown ina first stable position, or a storage configuration, in accordance withan exemplary embodiment of the invention. Elastomeric ring 2002 isinitially located in a first groove 2004, situated between an anchorsection 2006 of incontinence device 2000 and a second groove 2008 insome exemplary embodiments of the invention, is used to help maintaindevice 2000 in a storage configuration. In an exemplary embodiment ofthe invention, first groove 2004 is situated on body of device 2000where when elastomeric ring 2002 applies pressure to device 2000 fromfirst groove 2004 support 2010 and anchor 2012 arms are not urgedradially outwards.

In some exemplary embodiments of the invention, elastomeric ring 2002 iscomprised of latex, rubber, silicone, polyurethane or nylon. Optionally,elastomeric ring 2002 is constructed of any at least slightly elasticmaterial. In some exemplary embodiments of the invention, theelastomeric ring is not elastic and/or flexible. In some exemplaryembodiments of the invention, elasticity and/or flexibility aidelastomeric ring 2002 in moving from first groove 2004 to second groove2008 and/or remaining in the grooves 2004, 2008. For example, in someexemplary embodiments of the invention, ring 2002 uses its elasticability, like a rubber band, to apply pressure to device 2000 while ring2002 is in a groove, thereby helping to retain ring 2002 in the grooveand also in the case of first groove 2004 holding device in a storageconfiguration and in the case of second groove 2008 helping the radialexpansion of support 2010 and anchor 2012 arms. Optionally, theelastomeric ring is not ring shaped, it is optionally square,rectangular, triangular, ovoid, or u-shaped, for example.

Deployment of incontinence device 2000 transitions elastomeric ring 2002from a first stable position where ring 2002 is located in a firstgroove 2004 to a second stable position, where ring 2002 is located in asecond groove 2008, in accordance with some exemplary embodiments of theinvention. As device 2000 moves in an applicator 2014 towards anapplicator exit 2016, elastomeric ring 2002 hits a transition element2018 located on the interior surface of applicator 2014. Device 2000 issubjected to sustained pressure for deployment, urging device 2000 outof applicator 2014, while elastomeric ring 2002 is pushed by transitionelement 2018 down the exterior surface of device 2000 until it settlesinto second groove 2008. In some exemplary embodiments of the invention,second groove 2008 is adapted to prevent further movement of elastomericring 2002 as a result of transition element 2018, and further pressureon device 2000 deploys device 2000 into position, optionally in theuser's vagina. Optionally, first groove 2004 and/or second groove 2008are adapted to allow movement of ring 2002 out of first groove 2004 as aresult of encountering transition element 2018 but to prevent movementof ring 2002 out of second groove 2008. For example, second groove 2008is deeper than first groove 2004 in some exemplary embodiments of theinvention.

FIG. 20B shows incontinence device 2000 in the second stable position,or in a deployment configuration, where elastomeric ring 2002 is locatedin second groove 2008, in accordance with an exemplary embodiment of theinvention. When elastomeric ring 2002 is located in second groove 2008,anchor arms 2012 are urged radially outwards in part because of thecompressive force exerted by elastomeric ring 2002 at its second groove2008 position towards a central axis of device 2000 and because of apivot point 2020 created by the curvature of device 2000 at first groove2004 location. In some exemplary embodiments of the invention, the pivotpoint is created by the meeting of the two points on at least two of theanchor arms which are the lowest in the curvature of first groove 2004.In an exemplary embodiment of the invention, the support arms 2010 donot derive the benefit of a curved groove, like first groove 2004,therefore a pivot point is provided by positioning a pivot piece 2022between elastomeric ring 2002 and support arms 2010. Optionally, pivotpiece 2022 is a ball. In some exemplary embodiments of the invention,pivot piece 2022 is situated in a third groove 2024 adapted to receivepivot piece 2022 and prevent it from falling out prior to removal. Asabove, the pressure exerted by elastomeric ring 2002 and pivot piece2022 causes support arms 2010 to expand radially. In some exemplaryembodiments of the invention, the pressure exerted on device 2000 byelastomeric ring 2002 is varied depending on the length of the leverbetween ring 2002 and a pivot point (pivot point 2020 and/or pivot piece2022) and/or the effect desired to be achieved on device 2000.Additionally or alternatively, the flexibility of the material fromwhich device 2000 is constructed is also taken into consideration.

Referring to FIG. 20C, incontinence device 2000 is shown in a removalconfiguration, in accordance with an exemplary embodiment of theinvention. The radial profile of at least a portion of incontinencedevice 2000 is reduced to ease removal of device 2000, in some exemplaryembodiments of the invention. Optionally, reduction of the radialprofile is accomplished by dislodging pivot piece 2022 using a removaldevice 2026 attached to pivot piece 2022. In an exemplary embodiment ofthe invention, force applied on removal device 2026 away from cervix andtowards the direction of the user's vaginal opening causes pivot piece2022 to dislodge from third groove 2024. This dislodgement of pivotpiece 2022 removes a part of the mechanism from which support arms 2010were deriving radial expansion, allowing support arms 2010 to return toa reduced radial profile configuration. Sustained force on removaldevice 2026 away from the cervix eventually removes device 2000 from theuser's vagina. Removal device 2026 is optionally secured to incontinencedevice 2000 by threading it through the central node of device 2000 andprovided an enlarged end 2028 to prevent removal device 2026 from beingpulled out of device during removal. In some exemplary embodiments ofthe invention, device 2000 is provided with a cover 2030.

While not necessarily a bi-stable device in some exemplary embodimentsof the invention, the device depicted in FIG. 20D shows anotherexemplary embodiment of an incontinence device 2050 which uses anelastomeric ring 2052 to selectively apply pressure to device 2050.Incontinence device 2050 depicted in FIG. 20D is similar to many of theother embodiments described herein, which use an insert 2054 to radiallyexpand support arms 2056 and/or to provide support to support arms 2056against the counter-pressure exerted by the vaginal wall, and in thisembodiment elastomeric ring 2052, when device 2050 is deployed. Optionalinsert configurations which could be used with any of the embodimentsdescribed herein are depicted in FIGS. 20E-I. In some exemplaryembodiments of the invention, the hollow passage traversing the centerof the inserts is to allow the passage of a removal device. In someexemplary embodiments of the invention, the inserts are configured toachieve various radial expansion effects on the support arms of theincontinence device. Optionally, the inserts are configured to beremovably attached to the incontinence device.

In an exemplary embodiment of the invention, elastomeric ring 2052 actsin concert with the removal of insert 2054 to force radial contractionof support arms 2056 in order to ease removal of device 2050. In anexemplary embodiment of the invention, force applied to a removal device2058, as shown in FIG. 20E, dislodges insert 2054. This allows supportarms 2056 the freedom to converge towards the central axis of device2050, and elastomeric ring 2052 applies pressure to support arms 2056 toreinforce this contracting motion. In an exemplary embodiment of theinvention, upon sustained force away from the cervix of the user, thedevice 2050 is removed from the user's vagina.

An Exemplary Integrated Resilient Support Member Embodiment

FIG. 5 is a profile view of an incontinence device 500 with anintegrated resilient support member 502, in accordance with an exemplaryembodiment of the invention. Optionally, device 500 is any of thedevices described herein. In an exemplary embodiment of the invention,resilient support member 502 is used to bias the support arms 504 ofdevice 500. Optionally, support arms 504 are biased in an expandedradial configuration. Optionally, support arms 504 are biased in acompact radial configuration. Optionally, integrated support member 502is embedded within device 500. Optionally, integrated support member 502is located externally of the device 500, like an exoskeleton. In someexemplary embodiments of the invention, integrated support member 502 isused in conjunction with the support arms 504 of device 500. Integratedsupport member 502 is optionally constructed of a material with anenduring shape memory (such as stainless steel or polymers, such asnylon or silicone based materials). In an exemplary embodiment of theinvention, a shape memory integrated support member 502 imparts todevice 500 an extended shelf life since compressed in the applicator foran extended time will not substantially diminish the integrated supportmember's 502 spring coefficient. Integrated support member 502 isdesigned such that when device 500 is deployed from an applicator,integrated support member 502 forces support arms 504 to deploy radiallyoutwards from the central axis of device 500 for urethral support.Optionally, an integrated support member is used with the anchor arms508.

Removal of device 500 is assisted by attaching a removal device 506 tosupport arms 504. Downward force on removal device 506 away from thecervix causes support arms 504 to converge on the central axis of device500 enabling easier and/or more comfortable removal. Optionally, removaldevice 506 and integrated support member 502 are constructed of the samematerial. Optionally, removal device 506 and integrated support member502 are manufactured simultaneously. In other exemplary embodiments ofthe invention, integrated support members are used which bias supportand/or anchor arms towards the central axis of device 500 instead ofaway from the central axis. Such a configuration is optionally used toprovide better arm convergence for easier incontinence device removal.

Exemplary Tension Reducing Arms Embodiment

Referring to FIG. 6, a profile view of an incontinence device 600provided with tension reducing support and/or anchor arms 602 is shown,in accordance with an exemplary embodiment of the invention. Reductionin tension in support and/or anchor arms 602 extends the shelf life ofdevice 600. In an exemplary embodiment of the invention, the area of anincontinence device which undergoes the most stress and/or tension, thejoint between the support and/or anchor arms and the node, isreconfigured to distribute that stress and/or tension. Optionally, thestress and/or tension are reduced by spreading it out of a greater areaof the device. In an exemplary embodiment of the invention, tension isoptionally reduced on support and/or anchor arms 602 by providing themwith an accordion-like section 604 which folds in on itself whencompressed within an applicator. Optionally, folding is accomplishedwithout the use of hinges and/or other mechanical means. Optionally,other devices such as described herein are provided with tensionreducing arms such as shown in FIG. 6. However, upon deployment from theapplicator, in an exemplary embodiment of the invention, support and/oranchor arms 602 deploy themselves to expand radially from the centralaxis of device 500. In an exemplary embodiment of the invention, arms602 deploy to render mid-urethral support. Optionally, device 600 isused in conjunction with a cover, such as those described herein. Insome exemplary embodiments of the invention, device removal isfacilitated by applying a downward force, away from the cervix, to aremoval device attached to the cover encapsulating device 600. Asdescribed in other embodiments herein, this force causes the arms ofdevice 600 to converge towards the central axis of device 600, enablingan easier and/or more comfortable removal than without the armconvergence.

In an exemplary embodiment of the invention, an additional benefit ofsome embodiments of tension reducing devices is greater flexibility indevice size and/or applicator size. Optionally, the tension reductionconfiguration described herein permits the use of an incontinence devicethat has a wider diameter than would normally be suitable for use withan applicator, for example in the use of prolapse devices, whichgenerally require a larger diameter. Alternatively, a narrowerapplicator can be used for a tension reducing device which when deployedexhibits a similar radius to a non-tension reducing embodiment. In anexemplary embodiment of the invention, this is due to the folding natureof arms 602 which occupy less space when folded than when arms 602 areat full expansion. In another exemplary embodiment of the invention,folding arms enable the use of a longer central node than wouldtypically fit in an applicator, by increasing the length of foldingaccordion section 604.

Exemplary Scrolling Incontinence Devices

In some exemplary embodiments of the invention, incontinence devicescomprising at least one scrolling section are provided. Exemplaryembodiments are depicted in FIGS. 7A-D and 8. These devices 700, 800 aredistinguishable in at least one aspect from other incontinence devicesdescribed herein, in that rather than the support and/or anchor armsconverging towards a central axis in order to reduce the radial profileof the device, the scrolling sections are provided with the ability toroll up to reduce the radial profile of the device.

Referring to FIG. 7A, a profile view of a scrolling incontinence device700 is shown, in accordance with an exemplary embodiment of theinvention. Device 700 is comprised of a central member 702, which whendeployed optionally has a generally cylindrical shape. Optionally,located at or near the proximal and distal ends of central member 702are support arms 704 (proximal end) and anchor arms 706 (at distal end).In some exemplary embodiments of the invention, central member 702 iscomprised of a rolled sheet provided with arms 704, 706, as describedmore in detail with respect to FIG. 7C. In some exemplary embodiments ofthe invention, a removal device 708 is attached to device 700 tofacilitate removal. Removal device 708 is optionally attached to device700 such that when a downward force is applied to removal device 708away from the cervix, device 700 exhibits a deforming behavior towardsthe vaginal opening thereby reducing its profile for easier removal. Forexample, a removal force on removal device 708 optionally deforms theproximal end of device 700 into a conical-like shape, with the peakpointed towards the vaginal opening.

FIG. 7B is a profile view of another scrolling incontinence device 720embodiment, wherein device 720 has a flared proximal end, in accordancewith an exemplary embodiment of the invention. A flared proximal end isoptionally desirable in the treatment of incontinence in order toprovide additional support with the support arms 722 over device 700,which does not have a flared proximal end. In an exemplary embodiment ofthe invention, a flared proximal end allows the length of support arms722 to be shorter, reducing a source of potential discomfort upondeployment and/or use of device 720. Optionally, support arms 704, 722are variable in length depending on the requirements of the patient.Optionally, anchor arms 706 located at the distal end of devices 700,720 are variable in length depending on the requirements of the patient.Optionally, support and/or anchor arms are sufficiently long to preventvaginal tissue from becoming caught in the crease between the two endsof central member 702. In some exemplary embodiments of the invention,the support and/or anchor arms are up to 10 mm in length. Optionally,the arms are longer than 10 mms. Optionally, the arms are less than 5 mmin length. Optionally, support is rendered to the mid-urethra.

A top or bottom view of scrolling incontinence device 700, in accordancewith an exemplary embodiment of the invention, is shown in FIG. 7C. Itcan be seen that when viewed in conjunction with FIG. 7A, central member702 is optionally, generally cylindrical in shape. In some exemplaryembodiments of the invention, central member 702 is comprised of asheet, which is rolled to provide the generally cylindrical shape.Optionally, the sheet is comprised of a material which is biased tocause the sheet to open from the cylindrical shape but which isprevented from doing so when in an applicator or in a vagina, forexample.

Therefore, in an exemplary application, device 700 is rolled up like ascroll and placed in an applicator 730, shown in FIG. 7D. Device 700 isrolled such that its natural bias to open will cause device 700 toexpand into its generally cylindrical shape, and also exert at leastsome outward radial support pressure, upon deployment from applicator730. Optionally, support pressure is directed towards the mid-urethra.Optionally, device 720 is used as described herein with respect todevice 700.

Referring to FIG. 8, a double-sided, scrolling incontinence device 800is shown, in accordance with an exemplary embodiment of the invention.Device 800 is optionally comprised of a connecting node 802 which isprovided with scrolling, spring-like arm sections located on connectingnode's 802 proximal and distal ends. A support arm section 804 and ananchor arm 806 section optionally comprise the arm sections provided toconnecting node 802. In an exemplary embodiment of the invention, an armsection is comprised of a coiling strip 808 which defines a generallycircular profile around connecting node 802, as shown in FIG. 8.Optionally, a coiling strip 808 has protrusions 810 located thereon forproviding support and/or anchoring. In some exemplary embodiments of theinvention, at least the coiling strip 808 of the arm section isflexible. The flexibility of coiling strip 808 allows for compression ofthe strip in order to fit device 800 into an applicator. Furthermore,the flexible nature of coiling strip 808 optionally provides enhancedcomfort to a patient using device 800 as it tends to fit better to thepatient during movement than a rigid device. Optionally, connecting node802 is flexible. Optionally, protrusions 810 are flexible. Optionally,protrusions 810 are provided in varied lengths, such as described inconjunction with FIGS. 7A-D. Optionally, coiling strips defining largerand/or smaller radius circles are used with incontinence device 800,depending on the needs of the patient.

Exemplary Elasto-Mechanical Incontinence Device

Referring to FIGS. 19A-C, an incontinence device 1900 is shown which isprovided with an elasto-mechanical operation to achieve radial expansionand/or contraction, in accordance with an exemplary embodiment of theinvention. In some exemplary embodiments of the invention, at least oneexpander 1904 is provided to device 1900 connected to an anchor arm 1908or a support arm 1910 of the device 1900. An elastic member 1902 isprovided to incontinence device 1900 which, in some exemplaryembodiments of the invention, selectively causes expanders 1904 toradially expand and/or contract device 1900.

FIG. 19A shows incontinence device 1900 in a storage configuration (forexample, while in an applicator), in accordance with an exemplaryembodiment of the invention. Expanders 1904 are connected on one end toan expander node 1906 and on the other end to either anchor arm 1908 orsupport arm 1910, such that both ends of expanders 1904 can pivot withrespect to whatever it is attached to. In a storage configuration,elastic member 1902 is stretched, allowing expanders 1904 to pivot,permitting support arms and anchor arms to assume a reduced radialprofile.

FIG. 19B shows incontinence device 1900 deployed, in accordance with anexemplary embodiment of the invention. Elastic member 1902, previouslystretched during storage, contracts to its nominal state catching theexpander nodes with the enlarged ends 1912 of elastic member 1902 andforcing expanders 1904 into an expanded configuration. In an exemplaryembodiment of the invention, expanders 1904 push out their respectivearms causing device 1900 to expand its radial profile. The arms areconnected to a central node 1914 such that they may pivot to assumevarious operational configurations (e.g. storage, deployed, removal). Inan exemplary embodiment of the invention, support section enlarged end1916 is sized so that it would pass through the expander node but forthe safety catch 1918, which is removable as seen in FIG. 19C.

In FIG. 19C, incontinence device 1900 is shown in a removalconfiguration, in accordance with an exemplary embodiment of theinvention. Removal of device 1900 is optionally facilitated by reducingthe radial profile of device 1900. In an exemplary embodiment of theinvention, reducing the radial profile of device 1900 is achieved byremoving safety catch 1918, which nominally prevents support sectionenlarged end 1916 from passing through the expander node. Once supportsection enlarged end 1916 passes through the expander node, theexpanders for that node are free to collapse the support arms towards acentral axis of device 1900, at least in response to pressure exerted onthem by the vaginal wall. Optionally, expanders 1904 are at leastpartially elastic. Optionally, safety catch 1918 is removed by applyingforce on a removal device 1920 in a direction opposite the user's cervixand towards the vaginal opening. Optionally, security catch 1918 is tiedin a looseable knot, which comes undone upon the application ofsufficient force away from the cervix. Optionally, security catch 1918is comprised of a breakaway portion which causes catch 1918 to becomeunfastened to support section enlarged end 1916 when sufficient force isapplied to catch 1918 by removal device 1920. In some exemplaryembodiments of the invention, a cover 1924 is provided to incontinencedevice 1900. Optionally, removal device 1920 is affixed to cover 1924 toaid in removal of device 1900. In such an embodiment, sustained force onremoval device 1920 applied away from the user's cervix subsequentlycauses the reduced profile device 1900 to be pulled out of the user'svagina along with cover 1924.

Exemplary Embodiment of an Incontinence Device Provided With a TensileElement

Referring to FIG. 21A, an incontinence device 2100 is shown which isprovided with at least one tensile element 2102, in accordance with anexemplary embodiment of the invention. In some exemplary embodiments ofthe invention, at least one tensile element 2102 extends between arms ofan anchor section 2104 and corresponding arms of a support section 2106of incontinence device 2100. Optionally, at least one tensile element2102 is elastic. In some exemplary embodiments of the invention, atleast one tensile element 2102 is stretched prior to deployment and/orwhile being stored in an applicator 2108 in order to reduce the radialprofile of device 2100 and optionally, to provide force for expandingthe arms of support section 2106 during deployment.

FIG. 21B shows incontinence device 2100 in a deployed configuration, inaccordance with an exemplary embodiment of the invention. In someexemplary embodiments of the invention, at least one tensile element2102 substantially unstretches upon being deployed, providing adeployment force to support section 2106 and, optionally, anchor section2104 of incontinence device 2100. Optionally, the flexibility of anchorsection 2104 and/or support section 2106 is varied in order to controlthe response to at least one tensile element 2102. For example, in anembodiment where anchor section 2104 is not expected to display muchradial expansion, it would be suitable to decrease the flexibility ofanchor section 2104 so it would not respond to at least one tensileelement 2102 as it would have if it were more flexible. It should beunderstood that at least one tensile element 2102 can be used inconjunction with any of the incontinence devices described herein inorder to assist with incontinence device deployment.

Exemplary Lubricating Applicator Embodiments

In some exemplary embodiments of the invention, lubrication is providedto the applicator used for inserting a device into the vagina.Lubrication of the applicator eases its insertion and/or removal fromthe vagina and/or enhances the comfort to the user. FIGS. 9A-B, 10A-Band 24 depict exemplary embodiments of lubricating applicators.

FIG. 9A is a cross sectional view of an applicator 900 with alubricating ring 902, in accordance with an exemplary embodiment of theinvention. Applicator 900 serves for insertion of an incontinence deviceinto the vagina of a patient. Insertion is accomplished using thisapplicator in a similar fashion to inserting a regular menstrual tampon.In an exemplary embodiment of the invention, the incontinence device iskept within the distal end 904 of applicator 900 that is inserted intothe vagina. When pushing on a plunger 906 located at the proximal end ofapplicator 900, the incontinence device is pushed through the exit 908,allowing for utilization of the incontinence device once the applicator900 is removed from the vagina. It should be noted that in an exemplaryembodiment of the invention, the exit 908 remains closed until plunger906 is pushed and the incontinence device is forced out of applicator900. Optionally, exit 908 is comprised of a plurality of sections.

While introducing an incontinence device into the vagina with theapplicator 900, insertion is optionally facilitated by lubricatingapplicator 900. In an exemplary embodiment of the invention, lubricatingring 902 is provided to lubricate the external surface of applicator900. Optionally, ring 902 is slidable over the length of applicator inorder to provide lubrication at least over the area to be inserted intothe vagina. Optionally, lubrication is directed towards at least thedistal end of the applicator near the exit. Optionally, ring 902 ishollow. Materials located within ring 902 are optionally squeezed outfrom ring 902 via a plurality of small holes (not shown) located on ring902. In an exemplary embodiment of the invention, ring 902 is filledwith lubricant. Optionally, ring 902 is filled with a pharmaceutical.Optionally the small holes face applicator 900 such that when thematerials come out of ring 902 they are primarily deposited onapplicator 900. Optionally, ring 902 is constructed of a flexiblematerial, such as silicone. In an exemplary embodiment of the invention,ring 902 is pulled along applicator 900 while applying at least slightpressure to ring 902 in order to eject the materials within through theplurality of holes. As ring 902 moves along applicator 900, the materialis deposited on applicator 900 in accordance with the speed of movementof ring 902, pressure on ring 902, amount of material within ring 902and/or other variables. Ring 902 is optionally removed from applicator900 before applicator 900 is used to deploy a device. Optionally, ring902 remains on applicator 900 during device deployment and then isdisposed of, along with applicator 900.

Referring to FIG. 9B, a cross sectional view of an applicator 950 with aremovable cover 952 is shown, in accordance with an exemplary embodimentof the invention. Applicator 950 is optionally circumferentiallyenclosed by a removable cover 952. In an exemplary embodiment of theinvention, removable cover 952 seals between it and applicator 950 alayer 954 of a material such as a lubricant and/or a pharmaceutical.Optionally, removable cover 952 is manufactured from a substance, suchas polymers, nylon or aluminum foil, that preserves the lubricant and/orpharmaceutical material layer 954 for an extended period of time. Priorto insertion of applicator 950 into the patient's vagina, removablecover 952 is removed from applicator 950 to reveal material layer 954.Optionally, removable cover 952 and/or material layer 954 cover only aportion of applicator 950.

FIG. 10A illustrates a side view of an applicator 1000 with alubricating sleeve 1002 in accordance with an exemplary embodiment ofthe invention. Similar to the lubricating ring embodiment described withrespect to FIG. 9A, lubricating sleeve 1002 is used to ease insertion ofapplicator 1000 into a patient's vagina for incontinence devicedeployment by spreading a lubricant onto the exterior surface ofapplicator 1000. Optionally, lubricating sleeve 1002 is used to dispensea pharmaceutical onto applicator 1000. A cross sectional view ofapplicator 1000 is shown in FIG. 10B. In an exemplary embodiment of theinvention, lubricating sleeve 1002 is provided with a reservoir 1004which is used for storage of the lubricant and/or a pharmaceutical.Lubricating sleeve 1002 is optionally provided with a plurality ofoutlets whereby upon the release of the lubricant through the outlets,at least a portion of applicator 1000 receives coverage. In an exemplaryembodiment of the invention, lubricating sleeve 1002 is moved along thesurface of applicator 1000 to deposit lubricant. Optionally, lubricatingsleeve 1002 is removed from applicator 1000 by sliding it over thedistal end of the applicator prior to insertion of applicator 1000 intothe patient's vagina.

Referring to FIG. 24, a lubricating applicator 2400 is shown inaccordance with an exemplary embodiment of the invention. Applicator2400 operates in a similar fashion to deploy an incontinence device 2408as other applicators described herein, by applying pressure on a plunger2404 to expel device 2408 from an enclosure 2402 and into a vagina, inan embodiment of the invention. A lubricating layer 2406 is applied toapplicator 2400, optionally towards a proximal end 2410 of applicator toease insertion of applicator 2400 into a user's vagina. In someexemplary embodiments of the invention, lubricating layer 2406 iscomprised of a lubricant which is highly viscous. The highly viscouslubricant is applied at the proximal end of applicator 2400 at the timeof manufacture and remains in place during storage. At the time of use,the viscous lubricating layer 2406 eases insertion of applicator 2400into the user's vagina. Optionally, the lubricating layer 2406 iscomprised of silicone oil. Optionally, the lubricating layer 2406 iscomprised of glycerin. Optionally, the lubricating layer 2406 iscomprised of a petroleum jelly. Optionally, lubricating layer 2406 iscomprised of a viscous, water based material. Optionally, viscouslubricating layer 2406 is applied to any of the applicators describedherein.

Exemplary Applicator Embodiments for Improving Storage Conditions ofIncontinence Devices

In some exemplary embodiments of the invention, methods and apparatusesfor storing and applying incontinence devices are provided. FIGS. 11A-B,12A-D and 25A-C depict exemplary embodiments which allow for at least aportion of the device to remain in a substantially uncompressedcondition during storage. It is believed that reduction of the storagestresses on at least a portion of the device enhances performance and/orshelf life of the device.

Referring to FIG. 11A, a cross sectional view of an applicator 1100 anda loosely loaded incontinence device 1102 is shown, in accordance withan exemplary embodiment of the invention. Optionally, incontinencedevice 1102 is any of those described herein or radially expandable andknown in the art. Typically, storage of an at least partially elasticdevice in a compressed state reduces the efficacy of the devicesomewhat. In an exemplary embodiment of the invention, an incontinencedevice, such as some of those described herein, is only loosely loadedinto applicator 1100 in order to avoid degradation of incontinencedevice 1102 as a result of compression during storage within applicator1100. Optionally, loosely loaded comprises loading only an anchorsection 1104 of incontinence device 1102 into applicator 1100, whilesupport section 1106 and optionally central node 1108 remain outside ofapplicator 1100. In an exemplary embodiment of the invention, a loadingdevice 1110 is provided which is connected to incontinence device 1102and which extends through the applicator 1100 and out via an exit 1112located at a distal end of applicator 1100. Optionally, loading device1110 is removably connected to incontinence device 1102 so that afterloading device 1102 into applicator 1100, loading device 1110 is removedfrom applicator 1100. Optionally, loading device 1110 is string-like andis looped around incontinence device 1102 such that the two ends of thestring are accessible at exit 1112, as depicted in FIG. 11A.

Loading incontinence device 1102 into applicator is accomplished bypulling on loading device 1110 towards distal end of applicator which inturn pulls incontinence device 1102 into applicator 1100. Optionally,pulling is performed with clean hands to maintain the sterility ofapplicator. Optionally, a peel off layer is provided to applicator whichis removed after device 1102 is loaded into applicator 1100. In theembodiment depicted in FIG. 11A, both ends of loading device 1110 arepulled simultaneously to achieve loading. Removal of loading device 1110from applicator 1100 is optionally accomplished by pulling on one end ofloading device 1110 available at exit 1112 until the entire loadingdevice 1110 is pulled out of applicator 1100. In an exemplary embodimentof the invention, a plunger (not shown) is applied to the proximal endof applicator 1100 (where incontinence device 1102 was loaded) in orderto deploy incontinence device 1102 into a patient's vagina. Optionally,the plunger is provided separately from applicator 1150, shown in FIG.11B, and is used only when deployment of incontinence device 1102 isdesired.

FIG. 11B shows a cross sectional view of a flared proximal endapplicator 1150 which is loaded with an incontinence device 1102, inaccordance with an exemplary embodiment of the invention. Applicator1150 is provided with a flared section 1152 towards its proximal end. Asin the embodiment described with respect to FIG. 11A, incontinencedevice 1102 is only partially loaded into a narrow portion of applicator1150, whereas the remainder of incontinence device 1102 is positionedwithin flared section 1152. Optionally, flared section 1152 is sized toallow full expansion of the support section 1106 of incontinence device1102. In an embodiment of the invention, flared section 1152 is providedwith flared segments in number and size to accommodate each arm ofsupport section 1106. Optionally, flared section is at least partiallyconical shaped, and not provided with specific flared segments, but agenerally flared, conical shape for accommodation of device 1102irrespective of rotational orientation. Deployment of incontinencedevice 1102 is accomplished by using a plunger 1154 to urge incontinencedevice 1102 towards an exit 1156 located at the distal end of applicator1150. Optionally, plunger 1154 is provided with a shaped head 1158 inorder to stimulate convergence of support section 1106 towards thecentral axis of device 1102. Optionally, plunger 1154 is providedseparately from applicator 1150, and is used only when deployment ofincontinence device 1102 is desired. Optionally, flared section 1152begins its flare at the proper place on the applicator to indicatecorrect insertion depth. In an embodiment of the invention, applicator1150 is substantially open on the proximal end (not substantially closedas shown in FIG. 11B). In some embodiments of the invention, the openproximal end is provided with a lip, which corresponds to a lip onplunger 1154, designed to prevent plunger 1154 from dislocating fromapplicator 1150.

Referring to FIG. 12A, a side view of a slotted applicator 1200 with asliding sleeve 1202 is shown, in accordance with an exemplary embodimentof the invention. Sliding sleeve 1202 is optionally located on theexternal surface of applicator 1200 and is capable of movement up and/ordown the length of applicator 1200. It can be seen that applicator 1200is provided with a plurality of slots 1204 in an exemplary embodiment ofthe invention. Optionally, slots 1204 correspond in shape and/or numberto support arms of an incontinence device. In an exemplary embodiment ofthe invention, the shelf life of an incontinence device is lengthened byavoiding storage of the device in a compressed configuration within anapplicator. Instead, the support arms of an incontinence device 1206optionally project out of slots 1204 prior to deployment in a patient'svagina, as depicted in FIG. 12B.

FIG. 12C is a cross sectional view of slotted applicator 1200 withsliding sleeve 1202 loaded with incontinence device 1206, in accordancewith an exemplary embodiment of the invention. From this perspective, itcan be seen that incontinence device 1206, while within applicator 1200,is partially located outside of applicator 1200 and avoids compressionon the support arms 1208 during storage. In some exemplary embodimentsof the invention, sliding sleeve 1202 is provided with a reservoir 1210,from which substances may be deposited onto surface of applicator 1200.Optionally, reservoir 1210 is provided with a plurality of openingsbetween itself and applicator 1200 to deposit substances stored withinonto surface of applicator 1200. Optionally, a lubricant is a substancewhich is stored in reservoir 1210. Optionally, a pharmaceutical is asubstance stored within reservoir 1210. Substances in reservoir 1210 areoptionally deposited on applicator 1200 by moving sliding sleeve 1202 upand/or down the length of applicator's 1200 surface. In some exemplaryembodiments of the invention, lubricant is deposited on applicator 1200from reservoir 1210 prior to insertion of applicator 1200 in a vagina,in order to ease insertion of applicator 1200 into vagina and thedeployment of incontinence device 1206 stored within.

Referring to FIG. 12D, a side view of slotted applicator 1200 withsliding sleeve 1202 is shown wherein sliding sleeve 1202 is indeployment position, in accordance with an exemplary embodiment of theinvention. Prior to incontinence device 1206 deployment, sliding sleeve1202 is slid along applicator 1200 to its proximal end (closest to thevaginal opening when inserted in the vagina) where sliding sleeve 1202becomes locked into deployment position. The motion of sliding 1202sleeve pushes arms 1208 into slots 1204 readying them for deployment.Once sliding sleeve 1202 reaches deployment position, it is held inplace by a dent 1212 to prevent it from sliding back to the distal end1214 of applicator 1200. When sliding sleeve 1202 is in deploymentposition, arms 1208 are forcefully converged towards the central axis ofincontinence device 1206 such that the device is deployable fromapplicator 1200. In some exemplary embodiments of the invention, thesleeve does not rely on sliding for movement but instead screws up anddown applicator 1200 along threads located on external surface ofapplicator 1200.

FIG. 25A depicts an applicator 2500 which is comprised of a three partslotted applicator designed to reduce stress on an incontinence device2508 located therein during storage, in accordance with an exemplaryembodiment of the invention. Applicator 2500 includes an enclosure 2502,a slotted section 2504, and a plunger 2506 in an embodiment of theinvention. Slotted section 2504 is substantially cylindrical and isprovided with slots (similar to the slots of applicator 1200) whichcorrespond to the number and approximate size of support arms 2512 ofdevice 2508. While device 2508 is in storage, support arms 2512 jut outof the slots provided to slotted section 2504, thereby reducingcompressive stress forces on device 2508 and improving shelf life andperformance of device 2508. Optionally, support arms 2512 are protectedby a bag or cover while they are exposed.

In an exemplary embodiment of the invention, slotted section 2504 iscoaxially mounted on the inner circumference of enclosure 2502 such thatthe slots remain exposed, thereby allowing support arms 2512 of a device2508 located therein to jut out. Plunger 2506 is mounted coaxially onthe inner circumference of slotted section 2504, optionally with aprotrusion 2518 in contact with an insert 2510, insert 2510 being usedto cause support arm 2512 expansion for treatment rendering deployment.In an embodiment of the invention, plunger 2506 is slidable withinslotted section 2504 and slotted section 2504 is slidable withinenclosure 2502.

In an embodiment of the invention, slotted section 2504 fits frictionfits within enclosure 2502 such that it requires more force on plunger2506 to cause slotted section 2504 to slide within enclosure 2502 thanit does to attach insert 2510 to device 2508. In operation, depicted inFIG. 25B, plunger is moved by the user towards a distal end 2514 ofenclosure 2502 depositing insert 2510 in device 2508, but withoutsubstantially moving slotted section 2504. Once insert 2510 isdeposited, continued force on plunger 2506 towards distal end 2514causes slotted section 2504 to slide towards distal end 2514 ofenclosure 2502. It should be noted that although insert 2510 isrendering radial expansion force to support arms 2512 while device 2508is still within applicator 2500, the flexible nature of device 2508, andoptionally insert 2510, allows for temporary compression of device 2508prior to expulsion from applicator 2500 and deployment within the user'svagina. In an exemplary embodiment of the invention, device 2508 isdeployed shortly after insert 2510 is deposited into device 2508.

As shown in FIG. 25C, slotted section 2504 continues movement withinenclosure 2502 until a circumferential ring 2516 around the distal endof slotted section 2504 abuts enclosure 2502. Optionally, at least oneprotrusion is used in lieu of circumferential ring 2516. Continuedapplication of force on plunger 2506 ejects device 2508 from applicator2500 and the force of the insert 2510 on the support arms 2512 causesthem to radially expand in place in the user's vagina, thereby renderingurethral support to the user. Optionally, the support is mid-urethral.

Exemplary Collapsible Applicator Embodiment

Referring to FIG. 26A, an applicator 2600 is shown which in someembodiments is capable of assuming an axially collapsed configurationprior to use. In addition, applicator 2600 prepares an incontinencedevice 2604 for use during deployment, in some embodiments of theinvention. A collapsible applicator could be desirable for moreconvenient storage (takes up less space), for example. An enclosure 2602is provided to applicator 2600 which contains incontinence device 2604(device 2604 shown is that of FIGS. 27A-B) therein and while in acollapsed configuration, a large portion of a plunger 2606. In anexemplary embodiment of the invention, an insert 2612 used to helpdeploy device 2604 is attached to an activation/removal device 2608, forreasons described below. Optionally, activation/removal device 2608 isremovably fastened to applicator 2600 by a latch 2610.

In an exemplary embodiment of the invention, prior to use of applicator2600 to deploy incontinence device 2604, plunger 2606 is pulleddownwards to a configuration shown in FIG. 26B. Interfacing ledges 2614are provided on plunger 2606 and enclosure 2602 to prevent plunger 2606from dislodging from applicator 2600, in some embodiments of theinvention. The pulling action on plunger 2606 causes insert 2612 to passpartially through device 2604 since insert 2612 is attached toactivation/removal device 2608 and activation/removal device 2608 isfastened to plunger 2606 by latch 2610. An enlarged distal end of insert2612 prevents insert 2604 from passing completely through device 2604.The proximal end of insert 2612 is adapted to cause radial expansion ofsupport arms of device 2604, particularly upon deployment of device 2604out of applicator 2600 and as described with reference to FIGS. 27A-B.In an exemplary embodiment of the invention, latch 2610 is removed fromactivation/removal device 2608 to enable deployment of device 2604 fromapplicator 2600. Deployment is optionally effectuated by advancingplunger 2606 towards distal end of applicator 2600 and pushing device2604 out of applicator.

An Exemplary Plunger

FIG. 13 is a cross sectional view of a telescoping plunger 1300, inaccordance with an exemplary embodiment of the invention. In somesituations, it is desirable to minimize the size of the overallincontinence device package, which generally comprises an applicator, anincontinence device and/or a plunger, in some exemplary embodiments ofthe invention. The plunger, for example, is long enough to expel anincontinence device from an applicator but also has enough length thatit can be manually operated by the patient. In an exemplary embodimentof the invention, the plunger is reduced in size during storage byproviding telescoping plunger 1300. In order to shorten the devicepackage without changing dimensions of the applicator, the plunger isoptionally supplied in a “closed” or folded position which is expandedfor deployment of an incontinence device. In an exemplary embodiment ofthe invention, telescoping plunger 1300 is provided with two parts, oneinside the other. The outer part 1302 of plunger 1300 is partially heldinside the body of the applicator as with a non-telescoping plungerwhile the inner part 1304 of plunger 1300 is positioned at leastpartially within outer part 1302.

Deployment of plunger 1300 in an exemplary embodiment of the inventioninvolves holding inner part 1304 and pulling it away from outer part1302 into an “open” position. Continued pulling of inner part 1304 awayfrom outer part 1302 results in inner part 1304 locking into outer part1302 via an insert 1306 located on inner part 1304 which fits into arecess 1308 adapted to receive and/or interlock with insert 1306 onouter part 1302.

Plunger 1300 is optionally fitted with a ring 1310 which when insertedinto an applicator provides at least slight friction between plunger1300 and the applicator during relative movement between the two andalso to prevent plunger from freely falling out of the applicator.Optionally, ring 1310 is comprised of rubber. Optionally, ring iscomprised of a polymer based substance. Optionally, ring 1310 isflexible. In some exemplary embodiments of the invention, an applicatoris provided with a lip at its proximal opening where plunger is to beinserted. This lip is adapted to resist allowing passage of plunger 1300and ring 1310 without at least some modicum of force supplied by theperson inserting plunger 1300 into the applicator. In an exemplaryembodiment of the invention, once plunger 1300 is inside the applicator,this lip resists movement of plunger 1300 back out of the applicator,preventing inadvertent dislodgment of plunger from applicator.

Additional Exemplary Embodiments

It should be noted that a circular ring (not shown in any figures), butpreviously described in PCT/IL2005/000304, which is herein incorporatedby reference, may be located on any applicator in order to mark theproper depth of insertion of the applicator into the vagina. Optionally,the ring can be provided with selectable positions corresponding todifferent sized women, for personalization.

Furthermore, any of the incontinence devices described herein can beused in conjunction with a cover. In an exemplary embodiment of theinvention, a cover is made of a flexible, smooth mesh material.Optionally, the cover is porous. Optionally, the cover is designed assmall sack which encapsulates an incontinence device, which acts as aninternal support structure for the cover. Use of the cover canpotentially provide one or more benefits in using the device. Forexample, the cover optionally reduces friction between the applicatorand the device upon insertion. In addition, the cover optionally reducesfriction between the vagina and the device during insertion and/orremoval. In some embodiments of the invention, the mesh of the cover,being stretched between the arms of the device, serves as a sling-likesupport for the urethra. In a woman who leaks urine during a stressfulevent (when abdominal pressure rises during coughing, sneezing, etc.),the urethra sags down but meets the cover in its mid part. This causesan elevation of the intra urethral pressure with resultant urinarycontinence. Optionally, the cover provides support to the urethra. In anexemplary embodiment of the invention, the device does not put pressureagainst the urethra or the bladder neck, but only provides support whenthere is a rise in abdominal pressure, as described above. Optionally,the device applies direct pressure to the urethra and/or bladder neck.In some embodiments of the invention, the cover is disposable.Optionally, the cover is sterilized between uses and is reusable.Optionally, the cover is decorated.

In some embodiments of the invention, the cover assists with removal ofthe device from the vagina. First, the cover optionally reduces frictionbetween the incontinence device and the vaginal wall. Second, the coveris optionally provided with a removal device, such as a string.Optionally, the cover and the removal device are constructed of the sameunitary piece of material. The removal device optionally assists withthe removal of the device in a number of ways. Pulling the removaldevice causes tightening of the cover. Tightening of the cover causesthe straightening of the vaginal walls. The straightening of the vaginalwalls reduces the tent-like effect described above and relieves tensionapplied to the device, allowing for an easy and smooth removal of thedevice from the vagina. In addition, pulling on the removal deviceoptionally causes the support and anchor arms to fold slightly towardsthe central axis of the incontinence device, thereby reducing the radialsize of the incontinence device and allowing for an easy and smoothremoval of the device from the vagina. In an exemplary embodiment of theinvention, the device can be “walked” out of the vagina by pulling onremoval device causing the support arms to move towards the vaginalopening (and thereby pulling the anchor section along), releasing thestring suddenly, and then repeating the process.

In some exemplary embodiments of the invention, lubricant is deliveredby the incontinence device in response to a configuration change and/orduring removal of the device. Optionally, lubricant is contained withinthe incontinence device.

FIGS. 22A-C show cross-sectional views of incontinence devices, whichare by way of example only. In some exemplary embodiments of theinvention, different cross-sectional configurations are used formanipulating the tension and compression stresses applied toincontinence devices during storage, deployment, use and/or removal.Optionally, different cross-sectional configurations are used forreducing resistance to certain motions of the incontinence device and/orincreasing resistance to other motions. Optionally, differentconfigurations are used for preventing necrosis and/or discomfort to thewearer. These Figures are used to show some of the many possibilitiesavailable for the shape and configuration of the devices describedherein. For example, quadrilateral and ovoid shapes for the arms are notshown, but are also capable of use with the current inventions.

The present invention has been described using detailed descriptions ofembodiments thereof that are provided by way of example and are notintended to limit the scope of the invention. The described embodimentscomprise different features, not all of which are required in allembodiments of the invention. Some embodiments of the present inventionutilize only some of the features or possible combinations of thefeatures. Variations of embodiments of the present invention that aredescribed and embodiments of the present invention comprising differentcombinations of features noted in the described embodiments will occurto persons of the art. When used in the following claims, the terms“comprises”, “includes”, “have” and their conjugates mean “including butnot limited to”. The scope of the invention is limited only by thefollowing claims.

What is claimed is:
 1. An apparatus for treating urinary incontinencecomprising: a. a support section that provides urethral support; b. ananchoring section that resists movement of said apparatus in a vagina;and c. an insert separate from the support section and comprising ano-ring; wherein a portion of said insert is selectively positionedproximal to said support section and wherein said insert selectivelyprovides at least support to said support section of said apparatus. 2.The apparatus according to claim 1 wherein said insert provides pressureto said support section, causing radial expansion of said supportsection.
 3. The apparatus according to claim 1 wherein said supportsection is flexible.
 4. The apparatus according to claim 1 wherein saidsupport section comprises at least one arm.
 5. The apparatus accordingto claim 4 wherein the at least one arm is open-ended.
 6. The apparatusaccording to claim 1 wherein the insert is removably positioned in agroove of the support section when the insert is providing support. 7.The apparatus according to claim 1 wherein urethral support ismid-urethral support.
 8. The apparatus according to claim 1 furthercomprising a cover.
 9. The apparatus according to claim 8 wherein saidcover substantially encapsulates said apparatus.
 10. The apparatusaccording to claim 1 further comprising a removal device.
 11. Anapparatus for treating urinary incontinence comprising: a. a supportsection that provides urethral support; b. an anchoring section thatresists movement of said apparatus in a vagina; and c. an insertseparate from the support section and comprising a plurality ofgeometrically interlocking elements; wherein a portion of said insert isselectively positioned proximal to said support section and wherein saidinsert selectively provides at least support to said support section ofsaid apparatus.
 12. The apparatus according to claim 11 wherein saidinsert provides pressure to said support section, causing radialexpansion of said support section.
 13. The apparatus according to claim11 wherein said support section is flexible.
 14. The apparatus accordingto claim 11 wherein said support section comprises at least one arm. 15.The apparatus according to claim 14 wherein the at least one arm isopen-ended.
 16. The apparatus according to claim 11 wherein theplurality of geometrically interlocking elements includes at least oneof an internal insert, an external ring and a connecting device.
 17. Theapparatus according to claim 11 wherein urethral support is mid-urethralsupport.
 18. The apparatus according to claim 11 further comprising acover.
 19. The apparatus according to claim 18 wherein said coversubstantially encapsulates said apparatus.
 20. The apparatus accordingto claim 11 further comprising a removal device.